tag:blogger.com,1999:blog-13865918553003470682024-02-20T10:43:47.718-05:00Stem Cells That WorkStems Cells That WorkDNHhttp://www.blogger.com/profile/09946127168836977549noreply@blogger.comBlogger28125tag:blogger.com,1999:blog-1386591855300347068.post-22339638712041900612017-08-11T14:44:00.001-04:002017-08-11T14:49:54.687-04:00Minnesota sceptical of funding Human Embryonic Stem Cell Research<!--[if gte mso 9]><xml>
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Among those handful of states that fund embryonic as well as
other forms of stem cell research, Minnesota
is the newcomer.<span class="MsoEndnoteReference"><span style="mso-special-character: footnote;"><span class="MsoEndnoteReference"><span style="font-family: "times new roman"; font-size: 12.0pt;">[1]</span></span></span></span></div>
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<br /></div>
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Minnesota
is home to the nation’s first interdisciplinary institute dedicated to stem
cell research, the University of Minnesota Medical School’s <a href="https://www.stemcell.umn.edu/" target="_blank">Minnesota Stem Cell
Institute</a>, founded in 1999.<span style="mso-spacerun: yes;"> </span>Even so,
public funding for all forms of stem cell research there was approved only in
2014, with the first grants being made in 2015. This year’s grants mark the
third round of funding.<span style="mso-spacerun: yes;"> </span><a href="http://www.regenmedmn.org/">Regenerative Medicine Minnesota (RMM)</a> is
charged with approving and distributing the grants.</div>
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<br /></div>
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By way of comparison, both California
and Maryland
began funding stem cell research in 2007.<span style="mso-spacerun: yes;">
</span>More on this below.</div>
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<br /></div>
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In the three years that Minnesota has provided state funds for stem
cell research, it has noticeably steered clear of funding human embryonic stem
cell research (hESCR).</div>
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<br /></div>
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In 2015, <a href="http://www.regenmedmn.org/inaugural-research-awards">the first round of grant
making</a>, <span style="mso-spacerun: yes;"> </span>just under $3 million in
grants was given to six research projects.</div>
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<br /></div>
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None of them involved hESCR.</div>
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<br /></div>
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<a href="http://www.regenmedmn.org/2016-research-awards">In 2016</a>,
$2.75 million was distributed to 9 research projects.</div>
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<br /></div>
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Again, none of them utilized human embryonic stem cells
(hESCs).</div>
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<br /></div>
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<a href="http://www.regenmedmn.org/2017-regenerative-medicine-minnesota-research-awards">Ten
grants were awarded in 2017</a>, totaling just under $5 million.</div>
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<br /></div>
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Of the ten, nine explicitly funded non-embryonic stem cell
research. The research description for the tenth one creates some ambiguity, as
it refers to “pluripotent stem cells,” without specifying whether they are
embryonic or non-embryonic.</div>
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<br /></div>
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Nine of the grants were clearly non-embryonic.<span style="mso-spacerun: yes;"> </span>(Regarding the remaining grant, there is room
for ambiguity.<span style="mso-spacerun: yes;"> </span>The research description
refers to “pluripotent stem cells” which could refer to non-embryonic iPSCs, as
well as hESCs.)</div>
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<br /></div>
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As noted before on this blog (<a href="http://stemcellsthatwork.blogspot.com/2011/09/actions-speak-louder-than-words.html">here</a>,
<a href="http://stemcellsthatwork.blogspot.com/2013/04/watch-what-i-do.html">here</a>,
and <a href="http://stemcellsthatwork.blogspot.com/2017/07/another-state-prefers-non-embryonic.html">here</a>),
California and Maryland have in recent years strongly favored research using
adult, induced pluripotent and other forms of non-embryonic stem cell research
in their grant making.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
But this was not always the case.</div>
<div class="MsoNormal">
<br /></div>
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When both states handed out their first grants in 2007, they
strongly favored hESCR.<span style="mso-spacerun: yes;"> </span>Maryland gave only 4
grants to projects using adult stem cells, while 11 projects using hESCR
received grants – almost three times as many.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
California
first round of grants went to 72 research projects, all of them utilizing
hESCs.<span style="mso-spacerun: yes;"> </span>A second round of grants in 2007
went to 29 projects – again, all of them centered on hESCs (two also involved
somatic cell nuclear transfer, a.k.a., cloning).</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
This has changed over the years, with both states now
heavily favoring non-embryonic stem cell research in their grant making.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Minnesota,
in marked contrast, has given little, if any, support for hESCR.<span style="mso-spacerun: yes;"> </span>Why? Timing may provide an answer.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
California and Maryland began funding
stem cell research against a background of hype and hyperbole regarding the
potential of hESCs to cure any number of diseases and conditions.<span style="mso-spacerun: yes;"> </span>Human embryonic stem cells were hyped as the
“gold standard” in the field of regenerative medicine, while adult stem cell
research was dismissed as far inferior.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
All that began to change in 2007, when Shinya Yamanaka <a href="http://www.cell.com/cell/fulltext/S0092-8674(07)01471-7">discovered a method</a>
to produce what he called “induced pluripotent stem cells.”<span style="mso-spacerun: yes;"> </span>Like embryonic stem cells, these cells were
fully pluripotent.<span style="mso-spacerun: yes;"> </span>However, they did not
require the destruction of human embryos; they could be derived from a simple
somatic cell, such as a skin cell.<span style="mso-spacerun: yes;"> </span>With
a ready source of ethically non-contentious, fully pluripotent stem cells now
available, more and more researchers began turning to them rather than hESCs.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Moreover, adult stem cells were proving far more versatile
and effective in providing therapeutic benefits to patients than those who
dismissed them as inferior had predicted.<span style="mso-spacerun: yes;">
</span>While not yet providing cures, patients treated with adult stem cells
for such things as multiple sclerosis, spinal cord injury, diabetes and other
diseases began to show improvements from their treatments. In fact, over 1
million patients have been treated thus far with adult stem cells.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
When Minnesota
handed out its first stem cell grants in 2015, the changes the advent of iPSCs
had wrought in the field of regenerative medicine were evident. <span style="mso-spacerun: yes;"> </span>Also evident by then was the complete failure
of hESCR to live up to all the hype regarding miracle cures they were supposed
to bring about.<span style="mso-spacerun: yes;"> </span>Only a handful of
clinical trials were underway using hESCs; in contrast, the NIH on its website
listed thousands of clinical trials for patients using adult stem cells.<span class="MsoEndnoteReference"><span style="mso-special-character: footnote;"><span class="MsoEndnoteReference"><span style="font-family: "times new roman"; font-size: 12.0pt;">[2]</span></span></span></span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
It is thus not unreasonable to assume that given these
developments, Minnesota
decided to steer clear altogether of hESCR and instead provides funds for what
has proven to be far more promising adult, induced pluripotent and other
non-embryonic stem cell research. </div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<br /></div>
<div style="mso-element: endnote-list;">
<br clear="all" />
<hr align="left" size="1" width="33%" />
<div id="edn1" style="mso-element: endnote;">
<div class="MsoEndnoteText">
<span class="MsoEndnoteReference"><span style="mso-special-character: footnote;"><span class="MsoEndnoteReference"><span style="font-family: "times new roman"; font-size: 10.0pt;">[1]</span></span></span></span> The
other states are California, Maryland,
Connecticut and New York.</div>
</div>
<div id="edn2" style="mso-element: endnote;">
<div class="MsoEndnoteText">
<span class="MsoEndnoteReference"><span style="mso-special-character: footnote;"><span class="MsoEndnoteReference"><span style="font-family: "times new roman"; font-size: 10.0pt;">[2]</span></span></span></span> At <a href="http://www.clinicaltrials.gov/ct2/results?term=adult+stem+cell+transplants&type=Intr" target="_blank">http://www.clinicaltrials.gov/ct2/results?term=adult+stem+cell+transplants&type=Intr</a><br />
<span style="mso-spacerun: yes;"> </span><a href="https://www.washingtonpost.com/news/to-your-health/wp/2017/07/19/unapproved-stem-cell-treatments-touted-on-federal-database-clinicaltrials-gov-study-says/?utm_term=.9dcb66f91a0d">A
recent study</a> has questioned the validity of at least 18 trials listed on
the website.<span style="mso-spacerun: yes;"> </span>That still leaves several
thousand valid trials listed testing adult stem cells. </div>
</div>
</div>
DNHhttp://www.blogger.com/profile/09946127168836977549noreply@blogger.comtag:blogger.com,1999:blog-1386591855300347068.post-51010264482969283432017-07-25T11:40:00.001-04:002017-07-25T11:40:58.217-04:00Another State Prefers Non-Embryonic Stem Cell Research <!--[if gte mso 9]><xml>
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<div class="MsoNormal">
Maryland
is one of a handful of states to publicly fund embryonic stem cell research.<a href="https://www.blogger.com/blogger.g?blogID=1386591855300347068#_edn1" name="_ednref1" style="mso-endnote-id: edn1;" title=""><span class="MsoEndnoteReference"><span style="mso-special-character: footnote;"><span class="MsoEndnoteReference"><span style="font-family: "Times New Roman"; font-size: 12.0pt; mso-ansi-language: EN-US; mso-bidi-language: AR-SA; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-US;">[1]</span></span></span></span></a><span style="mso-spacerun: yes;"> </span>In 2006, the state established the <a href="http://www.mscrf.org/">Maryland Stem Cell Research Fund</a> (MSCRF),
which distributes grants to stem cell research projects.<span style="mso-spacerun: yes;"> </span>The first round of grants was in 2007, and
over the years the Fund has distributed millions of dollars to such research </div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
It is also home to the <a href="http://www.hopkinsmedicine.org/som/index.html">Johns Hopkins School of Medicine</a>,
one of the nation’s most prominent centers of stem cell research.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Earlier this year, the MSCRF released its <a href="http://www.mscrf.org/content/awardees/documents/2016AnnualReportFinalsmall.pdf">annual
report for 2016</a>.<span style="mso-spacerun: yes;"> </span>The report lists 26
research programs funded last year amounting to over $8.2 million.<span style="mso-spacerun: yes;"> </span>Fully 90% of the funds dispersed -- $7.7
million -- went to 22 projects using adult and other non-embryonic stem cell research.<span style="mso-spacerun: yes;"> </span>Only one project to receive a grant used
human embryonic stem cells (hESCs) exclusively (three used both hESCs and
induced pluripotent stem cells, aka iPSCs).<span style="mso-spacerun: yes;">
</span>That is a sea change from the first round of grants the MSCRF made in
2007.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
As with other states that first chose to fund hESC research,
Maryland did so in the wake of then-President George W. Bush’s 2001 decision to
fund hESCR, but to limit such funding to hESC lines already in existence.<span style="mso-spacerun: yes;"> </span>Some states chafed at such limits, and so
decided to fund the research on their own, without such restrictions.<span style="mso-spacerun: yes;"> </span>At the time, hESCs were being hailed by
scientists, politicians, celebrities and other public figures as having the
potential to cure any number of diseases and conditions – Alzheimer’s,
Parkinson’s,<span style="mso-spacerun: yes;"> </span>diabetes, heart failure and
spinal cord injury, among many others.<span style="mso-spacerun: yes;">
</span>Ethically non-contentious adult stem cell research, on the other hand,
was characterized as inferior, capable at best of only limited use in providing
therapeutic benefits to patients.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Thus, the grants distributed in <a href="http://www.mscrf.org/_media/client/pdf/awardees/2007_AnnualReport.pdf">2007</a>
by MSCRF reflected this belief.<span style="mso-spacerun: yes;"> </span>Out of
24 grants, 11 went to projects using hESCS, or 45%.<span style="mso-spacerun: yes;"> </span>Only 4 grants were given to research projects
centering on adult stem cells.<span style="mso-spacerun: yes;"> </span>The 11
hESC research projects received $5.2 million while the 4 adult stem cell
projects received less than half that - a mere $2.4 million.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
But over the years, this pattern began to shift, with an
increasing share of grants going to non-embryonic stem cell research (such as
adult and induced pluripotent stem cell research) and fewer to hESC research
projects.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
By <a href="http://www.mscrf.org/_media/client/pdf/2010annualreportweb.pdf">2010,</a>
this new pattern displayed a decisive turn away from hESCR and towards ethically
non-contentious, non-embryonic stem cell research. <span style="mso-spacerun: yes;"> </span>Funding for non-embryonic stem cell research
outstripped funding for hESCR 10 to 1, with the former receiving $9.9 million and
the latter just over $1 million.<span style="mso-spacerun: yes;"> </span>This
pattern will likely continue for as long as MSCRF continues to distribute
grants, as those distributed in 2016 once again shows.</div>
<div class="MsoNormal">
<br /></div>
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In the early years of the public policy debate over funding
for hESCR, numerous researchers affiliated then and now with Johns Hopkins
testified before Congress on the superiority of such research over all others
to advance the goals of regenerative medicine and on the urgent need to expand
federal funding for it.</div>
<div class="MsoNormal">
<br /></div>
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Over the years, Maryland’s
pattern of funding for stem cell research would seem to indicate that there has
been a clear change of mind on this.<span style="mso-spacerun: yes;"> </span>And
Maryland is not alone on this -- as this blog has noted before (<a href="http://stemcellsthatwork.blogspot.com/2017/07/normal-0-false-false-false.html">here</a>,
<a href="http://stemcellsthatwork.blogspot.com/2013/04/watch-what-i-do.html">here</a>,
and <a href="http://stemcellsthatwork.blogspot.com/2011/09/actions-speak-louder-than-words.html">here</a>),
California’s Institute for Regenerative Medicine – the nation’s largest funder
of stem cell research outside the federal government<span style="mso-spacerun: yes;"> </span>-- has also over the years shifted more and
more of its grants to non-embryonic stem cell research as well. </div>
<div class="MsoNormal">
<br /></div>
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These shifts in grant making by Maryland
and California
seem to indicate, at the very least, that hESCs can no longer be claimed as the
“gold standard” for stem cell research and providing therapeutic benefits to
patients.<span style="mso-spacerun: yes;"> </span>That claim now belongs to
research using ethically non-contentious, non-embryonic stem cells.<span style="mso-spacerun: yes;"> </span></div>
<div style="mso-element: endnote-list;">
<br clear="all" />
<hr align="left" size="1" width="33%" />
<div id="edn1" style="mso-element: endnote;">
<div class="MsoEndnoteText">
<a href="https://www.blogger.com/blogger.g?blogID=1386591855300347068#_ednref1" name="_edn1" style="mso-endnote-id: edn1;" title=""><span class="MsoEndnoteReference"><span style="mso-special-character: footnote;"><span class="MsoEndnoteReference"><span style="font-family: "Times New Roman"; font-size: 10.0pt; mso-ansi-language: EN-US; mso-bidi-language: AR-SA; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-US;">[1]</span></span></span></span></a> The
others are California, New
York, Connecticut and Minnesota.</div>
</div>
</div>
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</xml><![endif]-->DNHhttp://www.blogger.com/profile/09946127168836977549noreply@blogger.comtag:blogger.com,1999:blog-1386591855300347068.post-2138007179562055992017-07-06T15:55:00.001-04:002017-07-06T16:04:34.388-04:00CIRM Sponsored Clinical Trial Program Notable for Near Lack of hESCs<!--[if gte mso 9]><xml>
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<br />
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<div class="MsoNormal">
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The <a href="https://www.cirm.ca.gov/">California Institute
of Regenerative Medicine</a> (CIRM) is nearing the end of its ten year
term.<span style="mso-spacerun: yes;"> </span>Debate in California is ongoing as to whether CIRM
will actually close, or whether it will continue in a different form with
different funding sources.</div>
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<br /></div>
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The Alpha Stem Cell Clinics Network program may very likely
be one of the last major initiatives CIRM takes before its current term is over
sometime this year.<span style="mso-spacerun: yes;"> </span>As such, it is
emblematic of the funding course CIRM has travelled over the years.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
The Network’s goal, according to CIRM, <a href="https://blog.cirm.ca.gov/2017/03/27/cirm-alpha-clinics-network-charts-a-new-course-for-delivering-stem-cell-treatments/">“is
to accelerate the development and delivery of stem cell treatments to
patients.”</a><span style="mso-spacerun: yes;"> </span>To do this, CIRM
authorized the creation of up to 5 alpha clinics.<span style="mso-spacerun: yes;"> </span>These clinics are to be set up at academic
institutions across California
in order to serve as a “hub for stem cell clinical trials.” So far, <a href="http://www.businesswire.com/news/home/20170314006331/en/">three such clinics</a>
have been established, housed at City of Hope,
University of California/San Diego, and UCLA/UC Irvine.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Earlier this year, at City of Hope, the Network held its <a href="http://www.dailynews.com/health/20170325/symposium-discusses-latest-and-future-of-stem-cell-therapy">second
annual symposium</a>, where patients and doctors met to discuss ongoing
research and review progress in clinical trials underway.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
At the time the symposium was held, there were <a href="https://www.cirm.ca.gov/patients/alpha-clinics-network/alpha-clinics-trials">36
CIRM-funded</a> Alpha Stem Cell Network clinical trials underway, spread across
the three already established alpha clinics.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
This blog has called attention to the way that CIRM –
founded to give priority funding to human embryonic stem cell research – has
over the years been providing the lion’s share of its grants to adult and other
non-embryonic stem cell research.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
A look at the Alpha Stem Cell Network clinical trials shows
the same pattern of funding that has come to characterize so many of CIRM’s
grants: away from research using human embryonic stem cells (hESCs) in favor of
research using adult and other non-embryonic stem cell alternatives.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Only two of the trials listed on CIRM’s website utilize
hESCs. However, they are really the same trial, with two different phases, so
out of the 36 ongoing alpha network trials, only one is using hESCs.<span style="mso-spacerun: yes;"> </span>Moreover, although utilizing such cells, they
are not even the main focus of the trial.<a href="https://www.blogger.com/blogger.g?blogID=1386591855300347068#_edn1" name="_ednref1" style="mso-endnote-id: edn1;" title=""><span class="MsoEndnoteReference"><span style="mso-special-character: footnote;"><span class="MsoEndnoteReference"><span style="font-family: "times new roman"; font-size: 12.0pt;">[1]</span></span></span></span></a></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
The trial is being conducted by a company called <a href="http://viacyte.com/">ViaCyte.</a><span style="mso-spacerun: yes;">
</span>ViaCyte is testing <a href="http://viacyte.com/products/vc-01-diabetes-therapy/">a device</a> it is
developing that is intended to be placed under a patient’s skin, in order to
deliver pancreatic progenitor cells derived from hESCs.<span style="mso-spacerun: yes;"> </span>So the focus of the study is the <a href="https://clinicaltrials.gov/ct2/show/NCT02239354?term=VC-01&rank=1">performance
of the device</a>, not the efficacy of the stem cells it delivers for treating
diabetes.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
But should the device prove to be successful, it could
deliver non-embryonic derived stem cells useful for treating diabetes as well.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
For example, Harvard researcher Doug Melton <a href="http://www.cell.com/cell/abstract/S0092-8674%2814%2901228-8">has produced</a>
identical sets of mature, insulin producing beta cells from <i style="mso-bidi-font-style: normal;">both </i>hESCs and non-embryonic, induced
pluripotent stem cells.<span style="mso-spacerun: yes;"> </span>So if a device
such as Viacyte’s should prove successful in delivering cells, it could just as
well deliver ethically non-contentious, non-embryonic derived cells capable of
treating diabetes.<a href="https://www.blogger.com/blogger.g?blogID=1386591855300347068#_edn2" name="_ednref2" style="mso-endnote-id: edn2;" title=""><span class="MsoEndnoteReference"><span style="mso-special-character: footnote;"><span class="MsoEndnoteReference"><span style="font-family: "times new roman"; font-size: 12.0pt;">[2]</span></span></span></span></a> </div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
In fact, Melton is himself <a href="https://www.technologyreview.com/s/535036/a-pancreas-in-a-capsule/">working
on his own version</a> of such a device.<span style="mso-spacerun: yes;">
</span>Moreover, Melton has expressed concern that because the cells being used
by ViaCyte to test its device are embryonic-derived progenitor cells, not yet
fully differentiated to produce insulin, the cells may take months to mature
into true insulin producing cells.<span style="mso-spacerun: yes;"> </span>He
has also expressed concern that not all the progenitor cells will necessarily
develop into insulin producing ones, but rather could develop into other types
of pancreatic cells.<span style="mso-spacerun: yes;"> </span>Thus, while the
device itself may prove efficacious, the embryonic stem cell derived progenitor
cells it is intended to deliver may be far less so.<span style="mso-spacerun: yes;"> </span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
So as CIRM nears the completion of its original term, the
grants it has made to the Alpha Clinic Stem Cell Network are again confirming
that adult and other non-embryonic stem cells would appear to be showing the
most promise for helping patients. </div>
<div class="MsoNormal">
<br /></div>
<div style="mso-element: endnote-list;">
<br clear="all" />
<hr align="left" size="1" width="33%" />
<div id="edn1" style="mso-element: endnote;">
<div class="MsoEndnoteText">
<a href="https://www.blogger.com/blogger.g?blogID=1386591855300347068#_ednref1" name="_edn1" style="mso-endnote-id: edn1;" title=""><span class="MsoEndnoteReference"><span style="mso-special-character: footnote;"><span class="MsoEndnoteReference"><span style="font-family: "times new roman"; font-size: 10.0pt;">[1]</span></span></span></span></a> Eight of
the trials used adult stem cells and three iPSCs.<span style="mso-spacerun: yes;"> </span>Three used cells derived from fetal tissue,
which are considered adult stem cells, but which raise their own ethical
issues. The remaining trials are a mix consisting of the use of the patient’s
own cells and gene therapy.</div>
</div>
<div id="edn2" style="mso-element: endnote;">
<div class="MsoEndnoteText">
<a href="https://www.blogger.com/blogger.g?blogID=1386591855300347068#_ednref2" name="_edn2" style="mso-endnote-id: edn2;" title=""><span class="MsoEndnoteReference"><span style="mso-special-character: footnote;"><span class="MsoEndnoteReference"><span style="font-family: "times new roman"; font-size: 10.0pt;">[2]</span></span></span></span></a> In 1999,
then-President Clinton’s
National Bioethics Advisory Commission became the first such body to
investigate the ethical issues surrounding human embryonic stem cell
research.<span style="mso-spacerun: yes;"> </span><a href="http://bioethics.georgetown.edu/nbac/stemcell.pdf">NBAC made pursuit of
the research conditional</a>: harvesting “left-over” IVF embryos for stem cells
“is justifiable only if no less morally problematic alternatives are available
for advancing the research (at pg. 53).” In this instance, it would seem
there are indeed ethical alternatives to ViaCyte’s embryonic stem cell-derived
progenitors.<span style="mso-spacerun: yes;"> </span></div>
</div>
</div>
DNHhttp://www.blogger.com/profile/09946127168836977549noreply@blogger.comtag:blogger.com,1999:blog-1386591855300347068.post-77676232350062503932016-03-22T14:21:00.000-04:002016-03-22T14:21:43.662-04:00Supporting hESCR for Parkinson's: At the Fox Foundation, Not So Much<!--[if gte mso 9]><xml>
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<br />
<div class="MsoNormal">
The German drug discovery and development company Evotec
recently issued <a href="https://www.evotec.com/archive/en/Press-releases/2016/Evotec-awarded-grant-from-The-Michael-J-Fox-Foundation-for-Parkinson-s-Research/2806/1">a
press release</a> announcing a grant to develop drugs to treat Parkinson’s.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Nothing unusual about that – medical research and
development companies routinely issue press releases upon receiving a major
grant.<span style="mso-spacerun: yes;"> </span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
But what made this press release stand out was that the
grant was awarded by the Michael J. Fox Foundation (MJFF), for research using
non-embryonic stem cells.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Evotec’s Chief Scientific Officer <a href="https://www.evotec.com/uploads/cms_article/2806/PR_2016-02-02_MJFF_e.pdf">Dr.
Cord Dohrmann says</a> the grant is part of a larger “initiative to address
neurodegenerative diseases through highly innovative approaches involving
patient-derived stem cells and genetically validated mechanisms.”</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
“Patient-derived stem cells” – in other words, non-embryonic
stem cells.<span style="mso-spacerun: yes;"> </span>That MJFF is funding such
research is noteworthy, because Michael J. Fox himself has been a leading public
proponent of human embryonic stem cell research (hESCR) since 1998. <span style="mso-spacerun: yes;"> </span>While many Hollywood
celebrities advocated for such research, Fox was perhaps second only to the
late Christopher Reeve in promoting hESCR.<span style="mso-spacerun: yes;">
</span>He testified before Congress on several occasions that hESCR would be
the key to finding a cure for Parkinson’s.</div>
<div class="MsoNormal">
Yet non-embryonic stem cell alternatives now account for the
majority of research grants awarded by MJFF for stem cell research.<span style="mso-spacerun: yes;"> </span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
According to its website, since it launched in 2000, the
MJFF has awarded a total of <a href="https://www.michaeljfox.org/foundation/funded-grants.php?navid=funded-grants">1,345
research grants</a>.<span style="mso-spacerun: yes;"> </span>However, of that
total, a mere <a href="https://www.michaeljfox.org/foundation/funded-grants.php?srch=stem+cell&x=6&y=12&from=2000&to=&keyword=&country=&state=&institution=&researcher=&program_name=&organization=">66
grants</a> were for stem cell research<a href="https://www.blogger.com/blogger.g?blogID=1386591855300347068#_edn1" name="_ednref1" style="mso-endnote-id: edn1;" title=""><span class="MsoEndnoteReference"><span style="mso-special-character: footnote;"><span class="MsoEndnoteReference"><span style="font-family: "Times New Roman"; font-size: 12.0pt; mso-ansi-language: EN-US; mso-bidi-language: AR-SA; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-US;">[1]</span></span></span></span></a></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Of those 66, 48 directly involved the use of stems cells,
either human embryonic stem cells (hESCs) or adult and other non-embryonic stem
cells, such as induced pluripotent stem cells (iPSCs).<a href="https://www.blogger.com/blogger.g?blogID=1386591855300347068#_edn2" name="_ednref2" style="mso-endnote-id: edn2;" title=""><span class="MsoEndnoteReference"><span style="mso-special-character: footnote;"><span class="MsoEndnoteReference"><span style="font-family: "Times New Roman"; font-size: 12.0pt; mso-ansi-language: EN-US; mso-bidi-language: AR-SA; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-US;">[2]</span></span></span></span></a></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Thirty of the 48 grants, or 62.5%, were for adult, induced
pluripotent, or other non-embryonic stem cell research. <span style="mso-spacerun: yes;"> </span>Eighteen grants or 37.5% were for embryonic
stem cell research.<span style="mso-spacerun: yes;"> </span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Notwithstanding his past congressional testimony
enthusiastically endorsing hESC research, Michael J. Fox <a href="https://www.newscientist.com/article/dn21838-michael-j-fox-sidelines-stem-cells-for-parkinsons">admitted</a>
that “other avenues of research have grown and multiplied and have become as
much or more promising…an answer may come from [human embryonic] stem cell
research but it’s more likely to come from another area.”</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
As the majority of grants awarded by the Michel J. Fox
Foundation shows, those “other avenues” of research may not even involve stem
cells, whether adult or non-embryonic.<span style="mso-spacerun: yes;"> </span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
But the grants that the MJFF <i style="mso-bidi-font-style: normal;">has</i> awarded to stem cell research show a clear preference for
non-embryonic stem cell projects – an indication of their greater potential for
addressing Parkinson’s than the once highly touted hESCs.<span style="mso-spacerun: yes;"> </span></div>
<div class="MsoNormal">
</div>
<div style="mso-element: endnote-list;">
<br clear="all" />
<hr align="left" size="1" width="33%" />
<div id="edn1" style="mso-element: endnote;">
<div class="MsoEndnoteText">
<a href="https://www.blogger.com/blogger.g?blogID=1386591855300347068#_ednref1" name="_edn1" style="mso-endnote-id: edn1;" title=""><span class="MsoEndnoteReference"><span style="mso-special-character: footnote;"><span class="MsoEndnoteReference"><span style="font-family: "Times New Roman"; font-size: 10.0pt; mso-ansi-language: EN-US; mso-bidi-language: AR-SA; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-US;">[1]</span></span></span></span></a> The
result using the search engine on the <i style="mso-bidi-font-style: normal;">Funded
Grants</i> page to search the term “stem cell.” </div>
</div>
<div id="edn2" style="mso-element: endnote;">
<div class="MsoEndnoteText">
<a href="https://www.blogger.com/blogger.g?blogID=1386591855300347068#_ednref2" name="_edn2" style="mso-endnote-id: edn2;" title=""><span class="MsoEndnoteReference"><span style="mso-special-character: footnote;"><span class="MsoEndnoteReference"><span style="font-family: "Times New Roman"; font-size: 10.0pt; mso-ansi-language: EN-US; mso-bidi-language: AR-SA; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-US;">[2]</span></span></span></span></a> Fourteen
of the grants did not actually use human stem cells, either embryonic or
non-embryonic, or were for research using animal models, which virtually all
agree is ethically non-contentious.<span style="mso-spacerun: yes;"> </span>The
remaining four grants utilized cells derived from fetal tissue which makes them
adult, not embryonic stem cells. But because such tissue is harvested from
aborted fetuses, research utilizing it carries the same ethical baggage as hESC
research which, of course, requires the destruction of human embryos.</div>
</div>
</div>
DNHhttp://www.blogger.com/profile/09946127168836977549noreply@blogger.comtag:blogger.com,1999:blog-1386591855300347068.post-24163478955578014602015-07-02T15:27:00.000-04:002015-07-02T15:27:44.350-04:00Predictably Unpredictable<!--[if gte mso 9]><xml>
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<br />
<div class="MsoNormal">
Predictions about science can be, well, unpredictable.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
A recent posting on the science/technology website <i style="mso-bidi-font-style: normal;"><a href="http://gizmodo.com/why-scientific-americans-predictions-from-10-years-ago-1701106456">Gizmodo</a></i>
nicely makes the point.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
The author reviews a year-end issue of <i style="mso-bidi-font-style: normal;">Scientific American</i> from 10 years ago, December 2005, identifying
the top 50 scientific trends of the year and where those trends might lead. The
author was interested to see how accurate the magazine’s predictions turned out
to be 10 years later.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
On any number of the predictions, the actual outcomes either
fell far short or have not been fulfilled at all. <span style="mso-spacerun: yes;"> </span>Science can be predictably unpredictable.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
But for purposes of this blog, one prediction stands out. Topping
the list of 50 leading scientific trends for 2005 was: “<strong><span style="font-weight: normal; mso-bidi-font-weight: bold;">Patient-specific stem
cells that pave the way for stem cell therapy.”</span></strong></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Such a prediction was typical at that time, fueled by the <a href="http://www.sciencemag.org/content/303/5664/1669.full">dramatic announcement</a>
in March 2004 that South Korean researcher Woo Suk Hwang had succeeded in using
somatic cell nuclear transfer (SCNT) to create cloned human embryos. The goal
was to use these embryos to harvest stem cells genetically matched to the
original donor of the somatic cell used in the SCNT cloning process. Hwang
published a <a href="http://www.sciencemag.org/content/308/5729/1777.full">second
paper in 2005</a>, confirming his initial success while claiming improved
efficiency in the cloning process. </div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Hwang’s claim to be the first to create human embryos by
cloning garnered international attention and vaulted him into the top tier of scientific
researchers.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
This was because cloning was seen as the essential step to
realizing the promise of embryonic stem cells. Since 1998, when University of Wisconsin researcher James Thomson first
isolated human embryonic stem cells (hESCs) from so-called “leftover” IVF
embryos, they were <a href="http://www.americanthinker.com/articles/2010/08/playing_politics_with_stem_cel.html">hyped</a>
as the potential cure for all manner of diseases and conditions. The drawback
was that these stem cells would be subject to tissue rejection if injected into
a patient. Cloning appeared to offer a solution to this problem, since the patient’s
body would not reject its own cells. So cloning, in turn, was hyped as the key to
the future of regenerative medicine.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
For example, at <a href="http://www.gpo.gov/fdsys/pkg/CHRG-107shrg83684/pdf/CHRG-107shrg83684.pdf">a
February 2002 hearing</a> before the Senate Judiciary Committee, participants,
both Senators and witnesses from the scientific community hailed human cloning
as key to the future advance of medicine. As Sen. Dianne Feinstein said in her
opening remarks: “Many doctors and scientists have argued that we must protect
our ability to use cloning techniques to try to save and improve the lives of
those ravaged by disease and other ailments. In fact, nuclear transplantation
offers enormous potential for pro-viding cures to diseases such as cancer,
diabetes, cystic fibrosis, and heart disease, as well as conditions such as
spinal cord injuries, liver damage, arthritis, and burns… and many other
potential cures and treatments for a variety of diseases and ailments.”</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Other participants spoke of SCNT’s “very real promise” and “considerable
potential for developing new medical therapies for life-threatening diseases,”
and of how “essential” human cloning research was to the future of medicine.<span style="mso-spacerun: yes;"> </span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
In <i style="mso-bidi-font-style: normal;">The Scientific
Conquest of Death</i> (Libros en Red, 2004), leading cloning proponent Dr.
Michael West, claimed that cloning offered healing powers of literally biblical
proportions.<span style="mso-spacerun: yes;"> </span>In his essay “<a href="http://www.imminst.org/SCOD.pdf">Therapeutic Cloning</a>,” West wrote: “We
have been given two talents of gold. The first, the root of immortal human
life, is the human embryonic stem cell. The second is nuclear transfer
technology. Shall we, like the good steward of the Bible, take these gifts to
mankind and courageously use them to the best of our abilities to alleviate the
suffering of our fellow human beings, or will we fail most miserably and bury
these gifts in the earth?”</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
On August 1, 2001, West had testified to a Senate subcommittee
to similar effect: “On the scientific front, I think it's useful to point out
that mankind occasionally is given gifts, things that can greatly advance the
human condition. I think we've been given two in just recent history. The
first, as we've talked about at some length already this morning, is the human
embryonic stem cell. … A second gift we've been given is this miracle we call
cloning, or nuclear transfer.”</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Yet contrary to predictions by <i style="mso-bidi-font-style: normal;">Scientific American</i> as well as Pelosi, West and others, Hwang’s research
and SCNT did not pave the way to stem cell therapies.<span style="mso-spacerun: yes;"> </span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Why? As the <i style="mso-bidi-font-style: normal;">Gizmodo</i>
blog points, the prediction was based on a “breakthrough that turned out to be
one of the biggest cases of scientific fraud ever.”</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Towards the end of 2005, the credibility of Hwang’s research
findings came under intense scrutiny. His claim to be the first to successfully
clone human embryos and derive stem cells from them was revealed <a href="http://www.stemcellresearch.org/blog/real_lesson_korean_cloning/">to be completely
fraudulent</a>.<span style="mso-spacerun: yes;"> </span>By January 2006, <i style="mso-bidi-font-style: normal;"><a href="http://www.sciencemag.org/content/311/5759/335.2">Science<span style="font-style: normal;"> had retracted</span></a></i> both of Hwang’s papers.
It seemed the hype in favor of cloning was so great that it encouraged him to
exaggerate and even fabricate results. Yet the <i style="mso-bidi-font-style: normal;">Scientific American</i> prediction that “patient specific stem cells”
would pave the way for stem cell therapies was not entirely wrong. In fact, that
prediction is coming true -- but not the way proponents of cloning predicted. </div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
The prediction is becoming reality because of ethically
non-controversial research that does not rely on human cloning or the
destruction of human embryos.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
In 2007, Japanese scientist Shinya Yamanaka developed a
method to take an ordinary somatic cell – the same type of cell used for human
cloning -- and coax (i.e., induce) that cell to a fully pluripotent state, so
that it has many of the properties of an embryonic strem cell. He was able to
do this <a href="https://www.cellmedicine.com/news190/">without destroying
embryos or obtaining eggs for use in cloning</a>. Such cells are an exact
genetic match to the person the body cell was obtained from. <span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Since Yamanaka’s original breakthrough discovery, scientists
have refined and improved the technique for producing these “induced
pluripotent stem cells” (iPSCs). Dr. Yamanaka himself has won the Nobel Prize
for this scientific and medical advance. And iPSCs are helping to realize the
“vast potential” of stem cells for therapeutic benefits – a potential once
wrongly claimed for human cloning.</div>
<div class="MsoNormal">
<span style="mso-spacerun: yes;"> </span></div>
DNHhttp://www.blogger.com/profile/09946127168836977549noreply@blogger.comtag:blogger.com,1999:blog-1386591855300347068.post-27551346881710233462014-10-16T14:34:00.001-04:002014-10-20T14:41:47.654-04:00More Embryonic Stem Cell Hype, Less Reality and Ethics<i>Dr. Prentice is Senior Fellow for Life Sciences at the Family Research Council (FRC) and a founding member of Do No Harm: The Coalition of Americans for Research Ethics. This blog was <a href="http://www.frcblog.com/authors/david-prentice/">originally posted</a> by Dr. Prentice at the FRC website and is reposted here with his permission </i><br />
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<div class="MsoNormal">
More Embryonic Stem Cell Hype, Less Reality and Ethics</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Excitement over a newly-released paper on stem cells making
insulin is a tribute to the Harvard stem cell Press Office.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
The actual report is quite a bit less earth-shaking than you
might be led to believe by the Harvard press office.<span style="mso-spacerun: yes;"> </span>The science itself, in a paper from the lab
of Dr. Doug Melton <a href="http://dx.doi.org/10.1016/j.cell.2014.09.040">published
in the journal <i style="mso-bidi-font-style: normal;">Cell</i></a>, provides <a href="http://news.sciencemag.org/biology/2014/10/diabetes-stem-cell-recipe-offers-new-hope">an
incremental improvement</a><a href="https://www.blogger.com/null" name="_GoBack"></a> in the derivation of
functional (insulin-secreting) beta cells.<span style="mso-spacerun: yes;">
</span>Melton’s lab developed an improved method to generate millions of
insulin-secreting cells from human embryonic stem cells (hESC, which require
the destruction of a young human being) <u>and</u> from human induced
pluripotent stem cells (hiPSC, the stem cells created from normal skin cells,
without using embryos.)<span style="mso-spacerun: yes;"> </span>The multistep
protocol, which took 4-5 weeks and treatment with eleven different factors,
produced insulin-secreting cells which the paper termed “SC-β” cells, that
secreted about half the amount of insulin as normal adult beta cells from the
pancreas.<span style="mso-spacerun: yes;"> </span>Previous attempts resulted in
insulin-secreting cells that were immature and more like fetal than adult
cells.<span style="mso-spacerun: yes;"> </span>In this new report, the authors
note that global gene expression analysis showed “SC-β cells made <i style="mso-bidi-font-style: normal;">ex vivo</i> are most similar, but not
completely identical, to cadaveric beta cells.”<span style="mso-spacerun: yes;">
</span>The SC-β cells secreted insulin in response to different glucose levels
in the lab dish and when injected into immunocompromised mice.<span style="mso-spacerun: yes;"> </span>When the new SC-β cells were tested in a
diabetic mouse model, 5 out of 6 mice survived up to 4 months, compared to 1
out of 6 control mice.</div>
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<br /></div>
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<u>Embryonic Stem Cells Unnecessary</u></div>
<div class="MsoNormal">
The paper itself makes the case that embryonic stem cells
are not needed for even this incremental advance or any subsequent work.<span style="mso-spacerun: yes;"> </span>The authors tested batches of SC-β cells made
from hESC as well as from hiPSC.<span style="mso-spacerun: yes;"> </span>The
results were equivalent no matter the starting cell type.<span style="mso-spacerun: yes;"> </span>So for any future production of SC-β cells,
the authors have shown that no embryonic stem cells are necessary.</div>
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<br /></div>
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<u>Unanswered Questions—Transplant Rejection and Safety</u></div>
<div class="MsoNormal">
The paper and its results do not address some significant
questions related to these new SC-β cells—immune rejection and safety (tumor
formation).<span style="mso-spacerun: yes;"> </span>The cells were tested in
immunocompromised mice, so they were free from immune attack.<span style="mso-spacerun: yes;"> </span>This will be an issue in any potential
treatment if the SC-β cells are derived from hESC.<span style="mso-spacerun: yes;"> </span>Use of hiPSC made from a diabetic patient
might provide a way around immune attack on the SC-β.</div>
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<br /></div>
<div class="MsoNormal">
Safety, especially from aberrant cell growth including tumor
formation, is always an issue with pluripotent stem cells, especially
hESC.<span style="mso-spacerun: yes;"> </span>In the mouse experiment, the
authors note that large masses of tumors were not seen, but also point out: “A
much larger number of transplants and more extensive histological examination
will be needed to assess the possibility of undesired cell growth in the
grafts.”<span style="mso-spacerun: yes;"> </span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
While the Harvard press release discusses testing of an
implantation device to protect SC-β cells implanted into mice, this simply
makes the point that the issues of immune rejection, as well as keeping the
implanted cells from running free in the patient, have not been tackled.<span style="mso-spacerun: yes;"> </span>In the end, this combination device is simply
a potential cell-based insulin pump, not a cure for diabetes.</div>
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<br /></div>
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<u>Embryonic Stem Cells Questionable</u></div>
<div class="MsoNormal">
In the past, the obsession with ESC has led to some
questionable claims about their abilities to treat diabetes.<span style="mso-spacerun: yes;"> </span>Their ability to make authentic insulin, in
quantities that would be useful, were first trumpeted and then shown to be
incorrect and even artifactual (see, <i style="mso-bidi-font-style: normal;">e.g.,</i>
<a href="http://www.ncbi.nlm.nih.gov/pubmed/12532008">here</a> and <a href="http://dx.doi.org/10.2337/diabetes.53.10.2603">here</a>).<span style="mso-spacerun: yes;"> </span>In fact, <a href="http://dx.doi.org/10.1016/S0002-9440(10)62488-1">teratoma formation</a>
was often the result or even the <a href="http://dx.doi.org/10.1634/stemcells.2005-0397">inducer of insulin
secretion from ESC</a>.</div>
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<br /></div>
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In fact, the high-efficiency production of insulin-secreting
cells from hESC and hiPSC has been done before today’s announcement—<a href="http://dx.doi.org/10.1038/nbt.3033">similar results were published in
September 2014 by Rezania <i style="mso-bidi-font-style: normal;">et al.</i></a><span style="mso-spacerun: yes;"> </span>That report also failed to address the
questions that the current paper did not address, <a href="http://www.sciencedaily.com/releases/2014/09/140911180737.htm">such as
transplant rejection</a>.</div>
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<br /></div>
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<u>Other Ways to Make Insulin-Secreting Cells—No Embryonic
Stem Cells Needed</u></div>
<div class="MsoNormal">
The obsession with ESC continues to make headlines, but not
help patients.<span style="mso-spacerun: yes;"> </span>Even Melton’s lab has
shown various other ways to make insulin-secreting cells, including:
stimulating growth of pancreatic beta cells (which improves glucose tolerance)
by <a href="http://dx.doi.org/10.1016/j.cell.2013.04.008">expression of
betatrophin</a> growth factor; <a href="http://dx.doi.org/10.1038/nature07314">direct
reprogramming</a> to turn other pancreatic cells into new insulin-secreting
cells within the body; and <a href="http://dx.doi.org/10.1172/JCI32959">regeneration
of insulin-secreting beta cells</a> by the normal pancreas, achieved by
stopping the autoimmune attack typical of Type 1 diabetes.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
This latter result is important, because it addresses the
underlying cause of Type 1 diabetes:<span style="mso-spacerun: yes;"> </span>the
autoimmune attack on the insulin-secreting cells.<span style="mso-spacerun: yes;"> </span>Stopping the autoimmune destruction of beta
cells allows the body to regenerate normal, insulin-secreting cells from the
body’s own adult stem cells and progenitors.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Other scientists have shown the real promise of this
approach.<span style="mso-spacerun: yes;"> </span></div>
<div class="MsoNormal">
<a href="http://dx.doi.org/10.1371/journal.pone.0041756">Faustman
<i style="mso-bidi-font-style: normal;">et al.</i></a> used a simple treatment
with BCG to achieve a transient improvement in patients, providing proof of
principle for the concept.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal" style="mso-layout-grid-align: none; text-autospace: none;">
<a href="http://www.biomedcentral.com/1741-7015/10/3">Zhao <i style="mso-bidi-font-style: normal;">et al.</i></a> used cord blood-derived adult stem cells to “re-educate”
the immune cells of diabetic patients, providing lasting improvement in
metabolic control.</div>
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<br /></div>
<div class="MsoNormal" style="mso-layout-grid-align: none; text-autospace: none;">
The
best results thus far for Type 1 diabetic patients has resulted from the
collaboration of Voltarelli and Burt, using immunosuppression to remove rogue
immune cells followed by transplantation of <u>the patient’s own adult stem
cells</u>.<span style="mso-spacerun: yes;"> </span>Their success was <a href="http://dx.doi.org/10.1001/jama.297.14.1568">reported in 2007</a> and <a href="http://dx.doi.org/10.1001/jama.2009.470">in 2009 in <i style="mso-bidi-font-style: normal;">JAMA</i></a>.<span style="mso-spacerun: yes;"> </span>This was able to
induce complete remission (insulin independence) in most patients with early
onset type 1 diabetes mellitus.<span style="mso-spacerun: yes;"> </span><a href="http://content.time.com/time/health/article/0,8599,1891122,00.html">As
they noted</a> after publication of their second paper in 2009: “It's the first
therapy for patients that leaves them treatment-free — no insulin, no immune
suppression for almost five years.”<span style="mso-spacerun: yes;">
</span>Sadly, <a href="http://omicsonline.org/2157-7552/2157-7552-3-e119.php?aid=9545">Dr.
Voltarelli died in 2012</a>, but his team continues to work on effective
patient treatments.</div>
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<br /></div>
<div class="MsoNormal" style="mso-layout-grid-align: none; text-autospace: none;">
<b style="mso-bidi-font-weight: normal;"><u>Adult stem cells remain the gold
standard for real patient treatments.</u></b></div>
<div class="MsoNormal" style="mso-layout-grid-align: none; text-autospace: none;">
<br /></div>
DNHhttp://www.blogger.com/profile/09946127168836977549noreply@blogger.comtag:blogger.com,1999:blog-1386591855300347068.post-80220573968040374032014-10-10T14:29:00.000-04:002014-10-10T14:29:49.188-04:00Non-Embryonic Stem Cell “Alternatives” Again Taking the Lead<!--[if gte mso 9]><xml>
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<br />
<div class="MsoNormal">
The <i style="mso-bidi-font-style: normal;">New York Times</i>
has long been – and continues to be – a vocal advocate for human embryonic stem
cell research (e.g., <a href="http://www.nytimes.com/2006/07/18/opinion/18tue1.html?module=Search&mabReward=relbias%3As%2C%7b%222%22%3A%22RI%3A13%22%7d">here</a>).<span style="mso-spacerun: yes;"> </span>From the time hESCs were first isolated in
1998, the Times has published numerous editorials endorsing the research and
calling for federal funding of it.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
So a <a href="http://www.nytimes.com/2014/09/16/science/stem-cell-progress-begins-to-catch-up-to-promise.html?_r=0">recent
<i style="mso-bidi-font-style: normal;">Times</i> story</a> providing a look at
where stem cell research stands today was – no doubt unintentionally –
revealing.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
In marked contrast to the delirious enthusiasm with which
advocates promoted hESCR,<span style="mso-spacerun: yes;"> </span>promising it
would <a href="http://www.americanthinker.com/2010/08/playing_politics_with_stem_cel.html">lead
to cures for virtually all diseases and conditions</a> (one prominent
politician at the time said human embryonic stem cells could become a “<a href="http://www.americanthinker.com/2010/08/playing_politics_with_stem_cel.html">veritable
fountain of youth</a>”), the tone of the article is far more cautious and
restrained in assessing what advances have actually been made to date in the
field of<span style="mso-spacerun: yes;"> </span>stem cell research.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
The article’s title sets the newly sober tone: “The Trials
of Stem Cell Therapy;” “trial” here can mean “to test,” as in a clinical trial,
but also “difficult” as in the difficulties researchers face in bringing stem
cells to therapy.<span style="mso-spacerun: yes;"> </span>The article calls the
process “halting” and notes that “progress has been slow.”<span style="mso-spacerun: yes;"> </span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
But while progress may be “slow” and “halting” the article
does note some promising developments.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
And they are all being accomplished with adult and other
non-embryonic sources of stem cells.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
The article opens anecdotally, with the story of a heart
disease patient who lost one-third of his heart’s functioning ability.<span style="mso-spacerun: yes;"> </span>The patient volunteered for a medical trial
in which researchers injected adult stem cells, derived from the patient’s own
bone-marrow, directly into his heart.<span style="mso-spacerun: yes;">
</span>While the article notes that “It’s impossible to know for sure whether
the bone marrow cells’ descendants became heart muscle cells or if repairs were
spurred some other way,” doctors nonetheless were able to tell the patient that
his heart “is one-third of the way back to normal.”<span style="mso-spacerun: yes;"> </span>The patient himself is quoted saying, “My
quality of life is like night and day to before the treatment.”</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
The article further notes there are “as many as 4,500
clinical trials involving stem cells” currently underway in the U.S. for a
whole host of diseases and conditions, but it does not clarify that virtually
all of these trials are using non-embryonic stem cells.<span style="mso-spacerun: yes;"> </span>That’s because only three trials using
embryonic stem cells have been approved here: <a href="http://www.reuters.com/article/2011/06/16/advancedcell-stemcells-idUSN1626088320110616">two
are testing hESCs</a> in two types of macular degeneration; they are ongoing
and valid results have not yet been reported.<span style="mso-spacerun: yes;">
</span>The third approved trial was for spinal cord injury; however, <a href="http://stemcellsthatwork.blogspot.com/search?updated-min=2011-01-01T00:00:00-05:00&updated-max=2012-01-01T00:00:00-05:00&max-results=10">it
was halted</a> in 2011, a little over a year after it began. The
California-based Asterias Biotherapeutics Inc. recently announced that it would
<a href="http://www.bizjournals.com/sanfrancisco/blog/biotech/2014/08/embryonic-stem-cells-asterias-geron-spinal-cord.html">resume
the trial</a>.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Another sign of progress mentioned in the article is that
the California Institute of Regenerative Medicine (<a href="http://www.cirm.ca.gov/">CIRM)</a> has awarded over $2 billion since 2006
to stem cell researchers, and that it is enrolling patients for 10 clinical
trials.</div>
<div class="MsoNormal">
Unmentioned again, is the fact that the clear majority of
these trials all involve non-embryonic stem cells.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
A look at CIRM’s website shows a list <a href="http://www.cirm.ca.gov/our-progress/cirm-funded-clinical-trials">of eight
clinical trials</a> “directly funded by grants from CIRM.”<span style="mso-spacerun: yes;"> </span>Of these eight, just one employed embryonic
stem cells, and it was the one mentioned above for spinal cord injury that was
eventually shut down.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
As for CIRM’s $2 billion in research grants awarded, this
blog has noted several times that, over the years, more and more of the money
awarded by CIRM has gone to fund adult and other non-embryonic stem cell
research projects (<a href="http://stemcellsthatwork.blogspot.com/2013/04/watch-what-i-do.html">here</a>,
<a href="http://stemcellsthatwork.blogspot.com/2013/09/follow-money.html">here</a>,
and <a href="http://stemcellsthatwork.blogspot.com/2011/09/actions-speak-louder-than-words.html">here</a>).</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
The article also references the work being done using
non-embryonic, <a href="http://www.youtube.com/watch?v=HXvRbffAhn8&feature=player_embedded#!">induced
pluripotent stem cells (iPSCs)</a> for disease modeling and drug testing.<span style="mso-spacerun: yes;"> </span>Dr.<span style="mso-spacerun: yes;">
</span>Kevin Eggan of Harvard, the article notes, has used the iPSC process to
create patient-specific stem cells from two patients with ALS (i.e., Lou
Gehrig’s disease) and then coaxed those cells into becoming neurons.<span style="mso-spacerun: yes;"> </span>Dr. Eggan noticed a signaling defect between
those neurons that appeared to cause the neural degeneration typical of ALS.
After extensive testing on the iPSC-derived neurons, Dr. Eggan has singled out
a drug currently used to treat epilepsy that may correct the defect in the ALS
neurons, which he expects to test on patients by the end of this year.</div>
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<br /></div>
<div class="MsoNormal">
Commenting on the use of iPSCs for such disease modeling and
drug testing, Dr. Eggan said that “the whole process is something that’s never
been remotely possible before.”</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Other researchers agree.<span style="mso-spacerun: yes;">
</span>Earlier this year, in July, scientists used this <a href="http://www.ucdmc.ucdavis.edu/publish/news/newsroom/9116">same method to
study Down syndrome</a>, allowing them to discover a possible cause of the
condition and a possible drug to treat it. “The advent of induced pluripotent stem
cell technology has created exciting new approaches to model neurodevelopmental
and neurodegenerative diseases for the study of pathogenesis and for drug
screening,” said David Pleasure, a coauthor of the study.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
The more sober approach to reporting on the therapeutic
progress of stem cell research, as reflected in this <i style="mso-bidi-font-style: normal;">New York Times</i> article is, no doubt, a welcome development.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
But however “halting” such progress may be, it is important
to note, as the examples cited by the <i style="mso-bidi-font-style: normal;">Times</i>
article – however unwittingly – show, that virtually all of it is being made on
the <i style="mso-bidi-font-style: normal;">non</i>-embryonic stem cell front.</div>
DNHhttp://www.blogger.com/profile/09946127168836977549noreply@blogger.comtag:blogger.com,1999:blog-1386591855300347068.post-81425670417273837442014-08-04T10:11:00.001-04:002014-08-04T10:11:29.718-04:00Adult Taking Charge<!--[if gte mso 9]><xml>
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<br />
<div class="MsoNormal">
The California Institute for Regenerative Medicine’s (CIRM)
choice for its new head would have been unthinkable when the institute was
first established almost 10 years ago.<span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span>Yet today, it seems fitting, given the direction
stem cell research has taken over the same decade.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<a href="http://www.cirm.ca.gov/about-cirm/newsroom/press-releases/04302014/c-randal-mills-named-new-president-california%E2%80%99s-stem">C.
Randal Mills</a> recently took over as CIRM’s new president.<span style="mso-spacerun: yes;"> </span>Before taking his new post, Mills had been
president and CEO of <a href="http://www.osiris.com/index.php">Osiris Therapeutics</a>.<span style="mso-spacerun: yes;"> </span>Osiris pursues therapies based on stem cell
research, so in that regard, Mill’s appointment to head up CIRM would seem
highly appropriate. </div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
However, Osiris pursues <i style="mso-bidi-font-style: normal;">non-embryonic</i>,
<i style="mso-bidi-font-style: normal;">adult</i> stem cell research,
particularly with mesenchymal stem cells.<span style="mso-spacerun: yes;">
</span>That why his appointment would have been so unthinkable at CIRM’s
founding.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Apart from the federal government, CIRM is the nation’s
largest funder of stem cell research.<span style="mso-spacerun: yes;"> </span>As
noted before in this blogspot, CIRM was established for the express purpose of
giving priority funding for embryonic stem cell research and SCNT (i.e.,
cloning) over all other avenues of stem cell research.<span style="mso-spacerun: yes;"> </span>And in its early years, CIRM did just
that.<span style="mso-spacerun: yes;"> </span>But over the years, more and more
of CIRM’s grants have gone <a href="http://www.stemcellsthatwork.blogspot.com/2013/09/follow-money.html">to
support adult and other avenues of non-embryonic stem cell research</a> such as
induced pluripotent stem cell (iPSC) research.<span style="mso-spacerun: yes;">
</span>So in this regard, Mill’s appointment to head CIRM today makes perfect
sense.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Mills succeeds <a href="http://www.cirm.ca.gov/about-cirm/newsroom/press-releases/09132007/renowned-scientist-lead-california-stem-cell-institute">Alan
Trounson</a> as president of CIRM.<span style="mso-spacerun: yes;">
</span>Trounson was an enthusiastic supporter of human embryonic stem cell
research (hESCR), being one of the first Australian researchers to have
isolated hESCs.<span style="mso-spacerun: yes;"> </span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
In contrast, Mills has said he is “agnostic” when it comes
to stem cell research, <a href="http://www.huffingtonpost.com/robin-l-smith/c-randal-mills_b_5597049.html">explaining</a>
that “for me, it is all about getting stem cell solutions to patients.”<span style="mso-spacerun: yes;"> </span>In other words, Mills will not show any
favoritism towards funding hESCR projects over non-embryonic stem cell research
projects simply because they use embryonic stem cells; instead, funding will go
to projects that have the greatest chance of “bringing treatments to patients,
fast.”</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
In the context of CIRM’s founding mission to prioritize
funding for hESCR, Mills’ apparent refusal to do so is remarkable.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
It is, however an accurate reflection of how CIRM’s funding
has been shifting over the years towards funding non-embryonic stem cell
research projects.<span style="mso-spacerun: yes;"> </span>In fact, it is an
accurate reflection of how the whole field of regenerative medicine has shifted
over the years.<span style="mso-spacerun: yes;"> </span>Human embryonic stem
cell research has completely failed to live up to the hype it generated after
embryonic stem cells <a href="http://www.sciencemag.org/content/282/5391/1145.full">were first isolated</a>
in 1998.<span style="mso-spacerun: yes;"> </span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
And no longer can proponents of hESCR fairly claim that it
is the front-runner in the race to develop therapies for patients.<span style="mso-spacerun: yes;"> </span></div>
<div class="MsoNormal">
<br /></div>
DNHhttp://www.blogger.com/profile/09946127168836977549noreply@blogger.comtag:blogger.com,1999:blog-1386591855300347068.post-16792987967554351052014-05-20T10:24:00.000-04:002014-05-20T10:24:37.514-04:00Obsolete from the Start<!--[if gte mso 9]><xml>
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<br />
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
The <i style="mso-bidi-font-style: normal;">Washington Post</i>
gave a <a href="http://www.washingtonpost.com/opinions/in-stem-cell-research-the-potential-health-benefits-outweigh-the-ethical-risks/2014/04/20/dabdc824-c73c-11e3-8b9a-8e0977a24aeb_story.html">ringing
endorsement</a> to the recent news that scientists had<span style="mso-spacerun: yes;"> </span>succeeded once again <a href="http://www.washingtonpost.com/national/health-science/cloning-advance-using-cells-from-human-adult-raises-ethical-questions/2014/04/17/33a58222-c663-11e3-bf7a-be01a9b69cf1_story.html">in
creating cloned human embryos</a> and then destroying them for their stem cells
(about one year ago, another team of researchers became <a href="http://www.nytimes.com/2013/05/16/science/scientists-use-cloning-to-create-embryonic-stem-cells.html?action=click&module=Search&region=searchResults&mabReward=relbias%3Aw&url=http%3A%2F%2Fquery.nytimes.com%2Fsearch%2Fsitesearch%2F%3Faction%3Dclick%26region">the
world’s first to successfully create cloned embryos</a> for their stem cells,
but the original somatic cells used to create those cloned embryos came from
newborns and aborted fetus; this time, the somatic cells came from a 35-year
old and a 75-year old).</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
While noting that “some ethical worries are reasonable,” the
<i style="mso-bidi-font-style: normal;">Post</i> nonetheless concludes such
worries are “not enough reason to hold back this research.”</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
But in endorsing human cloning to obtain stem cells, the <i style="mso-bidi-font-style: normal;">Post</i> conveniently – and disingenuously –
ignored certain facts about the cloning process of somatic cell nuclear
transfer (SCNT). <span style="mso-spacerun: yes;"> </span>This process does not create stem cells as the
<i style="mso-bidi-font-style: normal;">Post</i> editorial misleadingly suggests;
it creates a human embryo that is then destroyed to obtain its stem cells (the <i style="mso-bidi-font-style: normal;">Post</i> is hardly alone in this – numerous
media outlets routinely use this journalistic sleight of hand when reporting on
this subject to mislead readers into believing that SCNT
directly produces stem cells).</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Interestingly, the <i style="mso-bidi-font-style: normal;">Post</i>
was not always so evasive. In an editorial from 10/2/94, the <i style="mso-bidi-font-style: normal;">Post</i> acknowledged cloning creates a human embryo and then opposed
doing this for any reason, including research and despite any theoretical
therapeutic benefits. “Do we want official support of human-cloning research in
this country? Do we want it anywhere?” the <i style="mso-bidi-font-style: normal;">Post</i>’s
editors asked, and they then answered “Potential medical benefits make this a
close call, but on balance the answer must be no. </div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
The <i style="mso-bidi-font-style: normal;">Post</i> even used
a “slippery slope” argument to oppose cloning to create human embryos for
research:</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
“Though therapeutic cloning for parts is not the same as
nurturing a human clone to birth, research that perfected the techniques needed
for the first purpose would bring the second closer. It is frequently said
that, whatever governments do, a human being sooner or later will be cloned.
That does not relieve governments of their obligation to do what they can to
block that creepy outcome.”</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal" style="margin-top: 6.0pt;">
Moreover, on 4/10/00, the <i style="mso-bidi-font-style: normal;">Post</i>'s editors reaffirmed this stance, and specifically opposed
cloning to create human embryos for stem cell research, saying it was “flat
wrong,” “unconscionable,” “alarming,” “a step too far” and that “the government
has no business funding it.”<span style="mso-spacerun: yes;"> </span>The
editorial also, like the earlier one, acknowledged cloning’s “slippery-slope
potential.”</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
In addition to the ethical problems with human cloning that
the <i style="mso-bidi-font-style: normal;">Post</i> once so clearly acknowledged,
there are practical problems with it as well.<span style="mso-spacerun: yes;">
</span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Cloning remains notably inefficient, requiring a large
number of eggs to produce very few stem cell lines, and the process of
obtaining the eggs <a href="http://www.cbc-network.org/2013/05/press-release-new-research-exploits-women-and-commodifies-human-life/">is
not without risks, some serious, to women.</a></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
The South Korean team that in April became the second to
successfully clone human embryos used <a href="http://www.cnn.com/2014/04/28/health/stem-cell-breakthrough/">77 eggs to
produce 2 stem cell lines</a> from the cloned embryos they created and
destroyed.<span style="mso-spacerun: yes;"> </span>That’s a 3 percent success
rate.<span style="mso-spacerun: yes;"> </span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Following this development, a New York team showed a slight increase in
efficiency, using 71 eggs to produce 4 stem cell lines from the embryos they
created and destroyed.<span style="mso-spacerun: yes;"> </span>That’s a 5.6%
success rate.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
According to the National Academy of Sciences (NAS), the <a href="http://www.nap.edu/openbook.php?record_id=10195&page=8">potential
U.S. patient populations for stem cell-based therapies</a> are as follows:</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<u>C</u><u><span style="color: black; font-family: "Tms Rmn"; layout-grid-mode: line;">ondition</span></u><span style="color: black; font-family: "Tms Rmn"; layout-grid-mode: line;"><span style="mso-tab-count: 3;"> </span><u>Number
of patients</u></span></div>
<div class="MsoNormal">
<span style="color: black; font-family: "Tms Rmn"; layout-grid-mode: line;">Cardiovascular disease<span style="mso-tab-count: 1;"> </span>58
million</span></div>
<div class="MsoNormal">
<span lang="FR" style="font-family: "Tms Rmn"; mso-ansi-language: FR;">Autoimmune diseases<span style="mso-tab-count: 2;"> </span>30
million</span></div>
<div class="MsoNormal">
<span lang="FR" style="color: black; layout-grid-mode: line; mso-ansi-language: FR;">Diabetes<span style="mso-tab-count: 3;"> </span>16
million</span></div>
<div class="MsoNormal">
<span lang="FR" style="mso-ansi-language: FR;">Osteoporosis<span style="mso-tab-count: 3;"> </span>10 million</span></div>
<div class="MsoNormal">
<span style="color: black; font-family: "Tms Rmn"; layout-grid-mode: line;">Cancers<span style="mso-tab-count: 3;"> </span>8.2
million</span></div>
<div class="MsoNormal">
<span style="color: black; font-family: "Tms Rmn"; layout-grid-mode: line;">Alzheimer’s disease<span style="mso-tab-count: 2;"> </span>5.5
million</span></div>
<div class="MsoNormal">
<span style="color: black; font-family: "Tms Rmn"; layout-grid-mode: line;">Parkinson’s disease<span style="mso-tab-count: 2;"> </span>5.5
million</span></div>
<div class="MsoNormal">
<span style="color: black; font-family: "Tms Rmn"; layout-grid-mode: line;">Burns (severe)<span style="mso-tab-count: 3;"> </span>0.3
million</span></div>
<div class="MsoNormal">
<span style="color: black; font-family: "Tms Rmn"; layout-grid-mode: line;">Spinal-cord injuries<span style="mso-tab-count: 2;"> </span>0.25
million</span></div>
<div class="MsoNormal">
<span style="color: black; font-family: "Tms Rmn"; layout-grid-mode: line;">Birth defects<span style="mso-tab-count: 3;"> </span>0.15
million/year</span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
These numbers give a total patient population of 133.9
million. But as the NAS notes, these conditions “occur in many forms and thus
not every person with these diseases could potentially benefit from stem cell
therapies.”<span style="mso-spacerun: yes;"> </span>Conservatively, let us say
that perhaps 10% of the total will be eligible for such therapies, or 13.4
million. </div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
At a success rate of 3%, treating this patient population
with stem cells derived from cloned embryos would require an astounding 446.6
million eggs. <span style="mso-spacerun: yes;"> </span>This in turn would require
29.7 million women to donate the average of 15 eggs per donor.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
At the more efficient rate of 5.6 percent, 239.3 million
eggs would be required to treat the potential patients for stem cell
therapies.<span style="mso-spacerun: yes;"> </span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
But now let’s assume scientist refine their skill at cloning
to achieve a 20 percent efficiency rate; some 67 million eggs would still be
required.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Let’s go even further:<span style="mso-spacerun: yes;">
</span>assume scientists achieve an astounding 90 percent efficiency rate; some
15 million eggs would still be required.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Now let’s say scientists became so skilled, they could
produce genetically matched stem cells from donors without using any eggs at
all!</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Oh wait….they’ve already done that.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
In 2007, Shinya Yamanaka became the first scientist to reprogram
a donor’s somatic cell (such as a skin cell) to generate fully pluripotent,
embryonic-like, genetically matched stem cells – no eggs or embryos involved.<span style="mso-spacerun: yes;"> </span>“<a href="http://www.cellmedicine.com/news190/">I’ve never used either</a>,”
Yamanaka said.<span style="mso-spacerun: yes;"> </span>Yamanaka dubbed these
stem cells “induced pluripotent stem cells” (iPSCs) because they are generated
by inducing somatic cells into a pluripotent state.<span style="mso-spacerun: yes;"> </span>So important was Yamanaka’s work to the field
of regenerative medicine that within just 5 years of his discovery he was
awarded a <a href="http://www.nytimes.com/2012/10/09/health/research/cloning-and-stem-cell-discoveries-earn-nobel-prize-in-medicine.html?pagewanted=1&_r=3&ref=science&">Nobel
Prize.</a></div>
<div class="MsoNormal">
<span style="mso-spacerun: yes;"> </span></div>
<div class="MsoNormal">
Numerous scientists have hailed these cloning developments
for the technical prowess involved in achieving them.<span style="mso-spacerun: yes;"> </span><a href="http://www.washingtonpost.com/national/health-science/oregon-scientists-get-stem-cells-from-cloned-human-embryos/2013/05/15/dc011cbc-bdac-11e2-9b09-1638acc3942e_story.html">“I
think part of the significance is technical</a> and part of the significance is
historical,” said John Gearhart, one of the first scientists to isolate, in 1998,
human embryonic stem cells. </div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
But they also noted that the therapeutic value for cloning
is probably not much.<span style="mso-spacerun: yes;"> </span>According to
Gearhart,”the more we learn about reprogramming, <a href="http://www.cnn.com/2014/04/28/health/stem-cell-breakthrough/">the more I
think IPS will be the one of choice</a>." <span style="mso-spacerun: yes;"> </span>Similarly, commenting on the work of the
Oregon team that first succeeded in creating cloned human embryos in 2013, MIT
professor Rudolf Jaenish, a vocal proponent of cloning for research, called
that development “an outstanding issue of whether it would work in humans has
been resolved,” but one, he added, that “<a href="http://www.washingtonpost.com/national/health-science/oregon-scientists-get-stem-cells-from-cloned-human-embryos/2013/05/15/dc011cbc-bdac-11e2-9b09-1638acc3942e_story.html">has
no clinical relevance</a>.”</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Non-embryonic stem cells are already achieving many of the
therapeutic benefits the Post now posits as merely potential for stem cells
derived from cloning. For example, scientists are producing whole organs from
patients’ own adult stem cells, such as <a href="http://www.cbsnews.com/news/cancer-patient-receives-stem-cell-made-windpipe-first-in-us/">tracheas</a>
that have already saved people’s lives.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
One wonders what has changed in the scientific and ethical
calculus to make the <i style="mso-bidi-font-style: normal;">Post </i>now embrace
what it once abhorred – especially since the argument for a need to go down
this path is weaker than ever.<span style="mso-spacerun: yes;"> </span></div>
<div class="MsoNormal">
<br /></div>
DNHhttp://www.blogger.com/profile/09946127168836977549noreply@blogger.comtag:blogger.com,1999:blog-1386591855300347068.post-73913646857733762302013-09-25T09:58:00.000-04:002013-09-25T09:58:04.323-04:00Follow the Money...<!--[if gte mso 9]><xml>
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<br />
<div class="MsoNormal">
As this blog has previously reported (<a href="http://stemcellsthatwork.blogspot.com/2013/04/watch-what-i-do.html">here</a>,
<a href="http://stemcellsthatwork.blogspot.com/2011/09/actions-speak-louder-than-words.html">here</a>,
and <a href="http://stemcellsthatwork.blogspot.com/2012/06/trend-continues.html">here</a>),
the <a href="http://www.cirm.ca.gov/">California Institute for Regenerative
Medicine (CIRM)</a> has over the years been steadily moving away from its
founding mission of giving funding priority to human embryonic stem cell
research (hESCR).<span style="mso-spacerun: yes;"> </span>Instead, since 2009 it
updated its strategic plan to give priority to funding projects most likely to
result in clinical trials; accordingly CIRM<span style="mso-spacerun: yes;">
</span>has been providing ever larger amounts of funding to adult stem cell and
other ethically non-contentious research alternatives to hESCR.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
CIRM’s most recent round of research grants, the Early Translational
IV Research Awards, again confirms this trend.<span style="mso-spacerun: yes;">
</span>According to CIRM, “<a href="http://www.cirm.ca.gov/our-funding/research-rfas/early-translational-iv">the
Early Translational Research Initiative</a> aims to fund and advance
potentially transformative stem cell therapies towards IND [Investigational New Drug]-enabling
preclinical and clinical development.”<span style="mso-spacerun: yes;"> </span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
In the <a href="http://www.cirm.ca.gov/about-cirm/newsroom/press-releases/08282013/stem-cell-agency-awards-more-40-million-new-research">fourth
round of grants under this Initiative</a>, announced in late August, only two
of the thirteen grants awarded were for projects using hESCs, while 10 grants
were for research using adult, induced pluripoternt stem cells (iPSCs) and
other non-embryonic stem cell approaches.<a href="http://www.blogger.com/blogger.g?blogID=1386591855300347068#_edn1" name="_ednref1" style="mso-endnote-id: edn1;" title=""><span class="MsoEndnoteReference"><span style="mso-special-character: footnote;"><span class="MsoEndnoteReference"><span style="font-family: "Times New Roman"; font-size: 12.0pt; mso-ansi-language: EN-US; mso-bidi-language: AR-SA; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-US;">[1]</span></span></span></span></a><span style="mso-spacerun: yes;"> </span>Of the total $40.6 million in grants awarded,
projects using ethically non-contentious alternatives to hESR received $34.1
million; research using human embryonic stem cells received $6.4 million.<span style="mso-spacerun: yes;"> </span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
A look at previous grants under the Early Translational
Research Awards category clearly confirms CIRM’s developing preference for
non-embryonic stem cell research as the best path leading to actual clinical
trials.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
The <a href="http://www.cirm.ca.gov/about-cirm/newsroom/press-releases/04292009/cirm-awards-67-million-move-basic-research-toward-clinic">first
round of such grants</a> came in 2009.<span style="mso-spacerun: yes;">
</span>Fifteen grants were awarded; nine for hESCR (three of which also
included iPSCs) with the remaining six going to research using adult and/or
induced pluripotent stem cells.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
With the <a href="http://www.cirm.ca.gov/about-cirm/newsroom/press-releases/10212010/cirm-funds-72-million-translate-basic-discoveries-new">second
round of Early Translational grants</a> in 2010 a clear preference for funding
non-hESCR emerges.<span style="mso-spacerun: yes;"> </span>The number of funded projects
using adult or induced pluripotent stem cells doubled from the previous year to
12, while only five projects were funded using hESCs.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
In 2012, <a href="http://www.cirm.ca.gov/about-cirm/newsroom/press-releases/05242012/california%E2%80%99s-stem-cell-agency-announces-international">a
third round of Early Translational grants</a> was awarded.<span style="mso-spacerun: yes;"> </span>Fifteen, or just over 70% of the 21 total
grants awarded went to adult and induced pluripotent stem cell research; the
remaining 6 grants went to hESCR projects.<span style="mso-spacerun: yes;">
</span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
In the 2013 round of grants, the percentage of those going
to non-hESCR increased to 77%.<span style="mso-spacerun: yes;"> </span>The
number of grants given to hESCR in 2013 fell to just 15% of the total, the
lowest percentage since the first round of Translational grants in 2009, when
hESCR received 60% of total grants awarded.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
The old Watergate-era adage advises that one should “follow
the money” to really get to the truth of the matter.<span style="mso-spacerun: yes;"> </span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
In the case of CIRM’s research grants over the past several
years, the truth is that when you follow the money, you find yet more evidence
that the future of regenerative medicine is with iPSCs, adult stem cells and
other ethically non-contentious alternatives to human embryonic stem cell
research.</div>
<div style="mso-element: endnote-list;">
<br clear="all" />
<hr align="left" size="1" width="33%" />
<div id="edn1" style="mso-element: endnote;">
<div class="MsoEndnoteText">
<a href="http://www.blogger.com/blogger.g?blogID=1386591855300347068#_ednref1" name="_edn1" style="mso-endnote-id: edn1;" title=""><span class="MsoEndnoteReference"><span style="mso-special-character: footnote;"><span class="MsoEndnoteReference"><span style="font-family: "Times New Roman"; font-size: 10.0pt; mso-ansi-language: EN-US; mso-bidi-language: AR-SA; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-US;">[1]</span></span></span></span></a> The
remaining grant was for research on cancer stem cell lines. </div>
</div>
</div>
DNHhttp://www.blogger.com/profile/09946127168836977549noreply@blogger.comtag:blogger.com,1999:blog-1386591855300347068.post-41519687599727095432013-04-30T14:47:00.000-04:002013-04-30T14:47:24.543-04:00Watch What I Do...<!--[if gte mso 9]><xml>
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<br />
<div class="MsoNormal">
With its <a href="http://www.cirm.ca.gov/about-cirm/newsroom/press-releases/03192013/stem-cell-agency-banks-32-million-new-approach-advance">most
recent round of grants</a> – the first for 2013 – the California Institute for
Regenerative Medicine (CIRM) continues its transformation from being one of the
world’s leading funders of human embryonic stem cell research (hESCR) to one
that increasingly supports non-embryonic research alternatives.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
In March, CIRM awarded $32 million under three categories of
awards.<span style="mso-spacerun: yes;"> </span>No funding went to hESCR.<span style="mso-spacerun: yes;"> </span>Instead, all of the funding was awarded to
programs to promote research using induced pluripotent stem cells (iPSCs).</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
A grant of $16 million was given to a program to produce 9,000
iPSC lines for use in research on various diseases.<span style="mso-spacerun: yes;"> </span>This is in vivid contrast to a previous round
of grants, in 2008, also to generate stem cell lines for research.<span style="mso-spacerun: yes;"> </span>Then, 16 projects were selected for funding: eight
projects were for generating hESCs (5 of these projects also involved iPSCs) while
the other eight were for projects involving iPSCs alone.<span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span>Now,
with this current round of grants, it appears CIRM no longer sees any value in
the creation of new hESC lines. </div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Something similar occurs with another of the March grants, a
$10 million award to create a bank to store, grow and make available iPSC lines
to researchers. That CIRM has not done the same to establish a bank to house
hESC lines would seem, again, to indicate that CIRM finds little value in doing
so.<span style="mso-spacerun: yes;"> </span>Indeed, as noted in a <a href="http://stemcellsthatwork.blogspot.com/2012/07/zero-interest-no-withdrawals_30.html">previous
blog</a>, one of the nation’s leading embryonic stem cell banks, the University of Massachusetts Stem Cell Bank, closed its
doors in 2012, just four years after its creation was approved.<span style="mso-spacerun: yes;"> </span>According to news reports, it had become
“obsolete.”<span style="mso-spacerun: yes;"> </span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
The remaining grant money was dispersed among 7 projects to
produce disease specific iPSC lines.<span style="mso-spacerun: yes;"> </span>This
is an area where iPSCs have clearly proved their utility in helping to develop therapies,
while regular adult stem cells are far ahead in terms of direct clinical use in
patients.<span style="mso-spacerun: yes;"> </span>Producing iPSCs from cells
donated from a patient (a patient with diabetes, Parkinson’s or heart disease,
for example) allows scientists to observe the origin and growth of that
particular disease and to test drugs to treat it.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
There is the old saying “Watch What I Do, Not What I Say.”</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Proponents of hESCR can still talk a good game on the
supposed ongoing “need” for hESCR.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
But when it comes to actually doing the research that has
the goal of producing cures and therapies, more and more researchers and
institutions, such as CIRM, are turning to induced pluripotent and adult stem
cell research and other non-embryonic alternatives.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<span style="mso-spacerun: yes;"> </span>After all, talk is
cheap, but research costs money and its supporters want results.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<br /></div>
DNHhttp://www.blogger.com/profile/09946127168836977549noreply@blogger.comtag:blogger.com,1999:blog-1386591855300347068.post-7521429990557182202013-03-01T14:26:00.000-05:002013-03-01T14:26:07.025-05:00Continuing to Ignore Their Own Advice -- Despite Continued Advances <!--[if gte mso 9]><xml>
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<br />
<div class="MsoNormal">
A study in the current issue of<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;"><a href="http://stemcellstm.alphamedpress.org/">Stem Cells Translational Medicine</a></i>
reports the use of<span style="mso-spacerun: yes;"> </span>neural stem cells
derived from induced pluripotent stem cells (iPScs) to treat amyotrophic
lateral sclerosis (ALS, also known as “Lou Gehrig’s Disease”) in rats.<span style="mso-spacerun: yes;"> </span>The study shows that the iPSc-derived neural
cells were able to engraft, survive and develop into mature neural cells in the
spinal cords of the ALS rats.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Dr. Roland Pochet of the Universite Libre de Bruxelles in Belgium,
who headed up the research teams, <a href="http://www.prweb.com/releases/2013/2/prweb10433560.htm">said the results</a>
“demonstrate proof-of-principle of survival and differentiation of human
iPSc-derived neural progenitors in <i style="mso-bidi-font-style: normal;">in
vivo</i> ALS environment, offering perspectives for the use of iPSc-based
therapy in ALS."</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Dr. Anthony Atala, editor of the journal in which the study
appeared, called the results “encouraging,” adding that beyond ALS they “suggest
the potential of cell therapy for the field of neurobiology and disease
treatment."</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
The announcement of the study’s results also noted that neural
cells had previously been derived from neural stem cells (NSCs) and embryonic
stem cells (ESCs) as well.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
But this development again demonstrates that along with
adult stem cells, iPScs are proving to be viable, ethically non-contentious
alternatives to the use of human embryonic stem cells; in this instance the
adult and iPSc-derived neural cells did everything the hESCs did, but without
having to destroy an embryo in the process.<span style="mso-spacerun: yes;">
</span><span style="mso-spacerun: yes;"> </span>Indeed this and other studies
show the continued pursuit of hESCR is ethically unjustified even by standards
first set by its proponents.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
In 1999, Presidents Clinton’s National Bioethics commission
(NBAC) <a href="http://bioethics.georgetown.edu/nbac/stemcell.pdf">first recommended
federal funding for hESCR</a>.<span style="mso-spacerun: yes;"> </span>The supposed
potential of the research deserved federal support, NBAC argued -- but on
condition.<span style="mso-spacerun: yes;"> </span>Given the inherent ethical
problems, NBAC judged it was “justifiable only if no less morally problematic
alternatives are available for advancing the research (at pg. 53).”<span style="mso-spacerun: yes;"> </span>In others words, if viable, ethically
non-contentious means existed for advancing such research and pursuing cures,
then hESCR should not be pursued at all. </div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Induced pluripotent stem cells are already replacing the use
of hESCs in several areas of research in the filed of regenerative medicine,
such as in disease modeling and drug testing.<span style="mso-spacerun: yes;">
</span>As noted in a <a href="http://stemcellsthatwork.blogspot.com/2012/06/trend-continues.html">previous
blog</a>, the California Institute of Regenerative Medicine, established to
give priority funding to hESCR, has over the years been shifting more and more
resources into adult stem cell and iPSC research.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Given these developments and others like it, one wonders:
why do proponents of hESCR continue to ignore the very standards they set down
in the 1999 NBAC report for pursuing it?</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<br /></div>
DNHhttp://www.blogger.com/profile/09946127168836977549noreply@blogger.comtag:blogger.com,1999:blog-1386591855300347068.post-12780982490193894872012-09-10T12:25:00.000-04:002012-09-10T12:25:10.547-04:00Another First<br />
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
This blog has on several occasions noted how the California
Institute for Regenerative Medicine
(CIRM) – established primarily to fund human embryonic stem cell
research (hESCR)—has instead in recent years been directing more and more of
its grants towards adult and other non-embryonic research projects. </div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Among the many categories of grants awarded by CIRM is the
Disease Team Research Awards. This
category was specifically established to fund projects that have the most
promise of actually leading to clinical trails.
The <a href="http://www.cirm.ca.gov/content/cirm-uk-and-canada-award-xxx-million-accelerate-pace-bringing-stem-cell-therapies-clinic">first
grants from this category</a> were awarded in October, 2009. <a href="http://stemcellsthatwork.blogspot.com/2011/09/actions-speak-louder-than-words.html">As
reported in a previous blog</a>, of the 14 grants awarded, only four went to
projects using embryonic stem cells. In
dollar terms, of the $250 million awarded in total, only $71.5 million went to
the 4 hESCR projects; the rest went to adult and other non-embryonic stem cell
research projects. Clearly, in 2009 CIRM
believed such avenues of research offered far more promise of resulting in
clinical trials than hESCR.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
And it turns out, that belief was not mistaken.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
The first CIRM-funded research project <a href="http://www.cirm.ca.gov/PressRelease_2012-07-09">to reach clinical trial</a>
was recently announced: to use <a href="http://www.cedars-sinai.edu/Patients/Programs-and-Services/Heart-Institute/Videos/How-the-Heart-Heals-Itself.aspx">adult
stem cells to treat heart disease</a>. The
researchers had received their funding under the above mentioned October, 2009
round of Disease Team Research Awards. </div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
The FDA approval was a “critical step in testing promising
therapies in patients,” Ellen Feigal, MD, Senior Vice President for Research
and Development at CIRM, said. “It’s a reflection of the initial progress being
made in advancing scientific discoveries towards potential therapies for
patients.”</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
The numbers also tell an interesting story. The four hESCR projects that received funding
during that same October 2009 round of grants received between $15 million and
$20 million each. In marked contrast,
the adult stem cell project that first reached clinical trial received far
less. In fact, it received the smallest
amount of all the projects funded under this round -- $5.5 million, or three to
four times less than the hESCR projects.
Yet it has proved the most promising.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Halfway into CIRM’s 10-year lifespan, some have questioned <a href="http://stemcellsthatwork.blogspot.com/2012/04/caveat-emptor.html">whether
it has a future</a> given the way it has fallen far short of the hype and
misplaced promises about therapies from hESCR.
The FDA approval of the CIRM-backed adult stem cell research project is
in this regard a much needed first for the Institute. </div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
It just wasn’t a first that hESCR proponents predicted or
expected. </div>
<div class="MsoNormal">
<br /></div>
<br />
<div class="MsoNormal">
<br /></div>
DNHhttp://www.blogger.com/profile/09946127168836977549noreply@blogger.comtag:blogger.com,1999:blog-1386591855300347068.post-53373797238481094632012-07-30T16:28:00.000-04:002012-07-30T16:28:50.575-04:00Zero Interest, No Withdrawals<!--[if gte mso 9]><xml>
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<br />
<div class="MsoNormal">
In the classic musical comedy “A Funny Thing Happened on the
Way to the Forum,” <span style="mso-spacerun: yes;"> </span>the Roman slave Pseudolus
tries to convince his master to free him by urging: <span style="mso-spacerun: yes;"> </span>“Be the first, start a trend!”</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Well, a funny thing has happened to those who started the
trend toward that bright future of miracle cures from human embryonic stem cell
research (hESCR).</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
As noted a number of times on this site, the California
Institute for Regenerative Medicine (CIRM) -- the nation’s largest funder of
stem cell research, founded for the express purpose of supporting human embryonic
stem cell research -- has in recent years been directing more and more of its
grants to adult and other non-embryonic stem cell research projects… a clear
sign that CIRM now sees adult stem cells and other alternatives as far more
likely to provide therapeutic benefits for patients than embryonic stem cells..
</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
And as noted in the previous blog, hESCR celebrity advocate Michael
J. Fox recently conceded that a cure for his Parkinson’s will in all likelihood
come from somewhere other than embryonic stem cells.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Now comes news that the University of Massachusetts
Stem Cell Bank will close when it runs out of
money at the end of the year. </div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
The reason?<span style="mso-spacerun: yes;"> </span><a href="http://articles.boston.com/2012-06-28/metro/32441864_1_cell-bank-cell-lines-cell-lab">It’s
become obsolete</a>, the <i style="mso-bidi-font-style: normal;">Boston Globe </i>reports,
citing state officials.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
The bank was launched with much fanfare in 2008, with a $7.7
million dollar grant from the state government.</div>
<div class="MsoNormal">
<br /></div>
<div class="loose">
“It takes a few seconds to get a glimpse of the precious cargo
loaded into the laboratory cooler that Dr. Gary Stein opens, mostly because of
the frosty fog that billows out. Then the air clears, and boxes of samples come
into view: human embryonic <a href="http://www.blogger.com/blogger.g?blogID=1386591855300347068" name="ORIGHIT_3"></a><a href="http://www.blogger.com/blogger.g?blogID=1386591855300347068" name="HIT_3"></a><span class="hit">stem</span> <span class="hit">cells</span>,” the (Worcester) <i style="mso-bidi-font-style: normal;">Telegram-Gazette</i> <a href="http://www.thefreelibrary.com/Lines+of+life%3B+Stem+cell+bank+launched+at+UMass.-a0185706470">breathlessly
began its report</a> on the bank’s opening.</div>
<div class="loose">
<br /></div>
<div class="MsoNormal">
Like CIRM, the Massachusetts
stem cell bank was established as a defiant response to President Bush’s policy
of limited federal funding for hESCR.<span style="mso-spacerun: yes;"> </span>Also
like CIRM, its main emphasis was to be on human embryonic stem cells, in this
case their storage and maintenance.<span style="mso-spacerun: yes;"> </span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
“Originally, the bank was seen as a repository for embryonic
stem cell lines that were being created but were not eligible for federal
funding under Bush-era restrictions,” the <i style="mso-bidi-font-style: normal;">Globe</i>
reports.<span style="mso-spacerun: yes;"> </span>The <i style="mso-bidi-font-style: normal;">Globe</i> further notes that the bank was “a marquee piece of Governor
Deval Patrick’s effort to bolster the life sciences industry” in Massachusetts.<span style="mso-spacerun: yes;"> </span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
But today?<span style="mso-spacerun: yes;"> </span>Citing
Terence Flotte, dean of UMass
Medical School,
“the bank receives one to two requests a week,” the <i style="mso-bidi-font-style: normal;">Globe</i> reports.<span style="mso-spacerun: yes;"> </span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Susan Windham-Bannister, president of the Massachusetts Life
Sciences Center, said the bank was “absolutely state of the art” when it first
opened.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
But if the number of weekly requests just cited is any
indicator, today the bank is closing due to a pronounced indifference to what
it has to offer – human embryonic stem cell lines.<span style="mso-spacerun: yes;"> </span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Zero interest, no withdrawals.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
CIRM, Michael J Fox and now the University of Massachusetts
Stem Cell Bank, all rethinking and moving away from
hESCR or even closing altogether.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Starting a trend?</div>DNHhttp://www.blogger.com/profile/09946127168836977549noreply@blogger.comtag:blogger.com,1999:blog-1386591855300347068.post-66075655968788705832012-06-25T10:46:00.000-04:002012-06-25T10:46:16.749-04:00Better Late Than Never<!--[if gte mso 9]><xml>
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<br />
<div class="MsoNormal">
Like CIRM, others are rethinking all the hype for hESCR and
coming to realize that the real promise of stem cell research in all
probability lies elsewhere, in adult and other non-embryonic avenues.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
For more than a decade, Michael J. Fox has been a leading
celebrity advocate for human embryonic stem cell research.<span style="mso-spacerun: yes;"> </span>As the <i style="mso-bidi-font-style: normal;"><a href="http://www.newscientist.com/article/dn21838-michael-j-fox-sidelines-stem-cells-for-parkinsons.html">New
Scientist</a></i> recently put it, Fox “was on the front line of the US's ‘stem
cell wars’, arguing that embryonic stem cells could cure conditions like his
own – Parkinson's disease.”</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
In testimony before a Senate subcommittee in 2000, Fox
referred to the “miraculous potential” of human embryonic stem cells and
claimed that the “consistent and inescapable conclusion is that this research
offers a potential to eliminate diseases -- literally save millions of lives.”<a href="http://www.blogger.com/blogger.g?blogID=1386591855300347068#_ftn1" name="_ftnref1" style="mso-footnote-id: ftn1;" title=""><span class="MsoFootnoteReference"><span style="mso-special-character: footnote;"><span class="MsoFootnoteReference"><span style="font-family: "Times New Roman"; font-size: 12.0pt; mso-ansi-language: EN-US; mso-bidi-language: AR-SA; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-US;">[1]</span></span></span></span></a></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Fox also was a vigorous advocate for passage of California’s Proposition
71, which established CIRM.<span style="mso-spacerun: yes;"> </span>In a <a href="http://www.prnewswire.com/news-releases/yes-on-proposition-71-launches-statewide-ads-featuring-michael-j-fox-74319497.html">commercial
he taped</a> Fox declared “[Prop] 71 will support research to find cures for
diseases that affect millions of people ... including cancer, diabetes,
Alzheimer's and Parkinson's.<span style="mso-spacerun: yes;"> </span>Please
support the effort to find cures by voting Yes on 71.<span style="mso-spacerun: yes;"> </span>It could save the life of someone you
love."</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
But in a <a href="http://news.yahoo.com/video/newsmakers-26771768/michael-j-fox-on-stem-cell-research-29331644.html">recent
interview</a> with ABC News’ Diane Sawyer, Fox’s take on the ability of hESCR
to deliver cures was far different, as he expressed an outright skepticism that
such research will ever live up to its hype– hype that he had a very prominent
role in promoting. </div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Sawyer broached the topic with Fox by characterizing hESCR
as “this is the promise, this is the future” (had she been a lawyer and this
was a courtroom, that would clearly be called “leading the witness”).</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Ten years ago, Fox doubtless would have enthusiastically
agreed.<span style="mso-spacerun: yes;"> </span>But now, his response was highly
qualified and cautious:<span style="mso-spacerun: yes;"> </span>“The other
avenues of research have grown and multiplied and have become as much or more
promising,” Fox replied.<span style="mso-spacerun: yes;"> </span>“So an answer
may come from stem cell research but it’s more likely to come from another
area.”</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Those other areas, according to the <i style="mso-bidi-font-style: normal;"><a href="http://www.newscientist.com/article/dn21838-michael-j-fox-sidelines-stem-cells-for-parkinsons.html">New
Scientist</a></i> “are speeding towards clinical trials. These include
neurotrophic factors – proteins that promote the survival of nerve cells – as
well as antibodies that target the alpha-synuclein protein, which may be a
cause of the brain damage seen in Parkinson's.”</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Proponents of hESCR should have displayed such realism and
caution over the last decade in the public policy debate on stem cell research,
rather than the hype and exaggeration they resorted to instead.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
“It's time to act on what we've learned,” said Mr. Fox in
2000.<span style="mso-spacerun: yes;"> </span>“Further delay would come at a
high price.”<span style="mso-spacerun: yes;"> </span>Treatments from adult and
other non-embryonic stem cell research were indeed almost certainly delayed, as
public attention and resources were diverted for years toward the largely
disappointing avenue of research based on embryo destruction.<span style="mso-spacerun: yes;"> </span>Advocates who called for such diversion may
now be realizing that it is their agenda that slowed authentic progress.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
But as the saying goes, better late than never. </div>
<div style="mso-element: footnote-list;">
<br clear="all" />
<hr align="left" size="1" width="33%" />
<div id="ftn1" style="mso-element: footnote;">
<div class="MsoEndnoteText">
<a href="http://www.blogger.com/blogger.g?blogID=1386591855300347068#_ftnref1" name="_ftn1" style="mso-footnote-id: ftn1;" title=""><span class="MsoEndnoteReference"><span style="mso-special-character: footnote;"><span class="MsoEndnoteReference"><span style="font-family: "Times New Roman"; font-size: 10.0pt; mso-ansi-language: EN-US; mso-bidi-language: AR-SA; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-US;">[1]</span></span></span></span></a><span class="hit">Testimony before the Senate Committee on Appropriations, Subcommittee
on Health, 9/14/00</span></div>
<div class="MsoFootnoteText">
<br /></div>
</div>
</div>DNHhttp://www.blogger.com/profile/09946127168836977549noreply@blogger.comtag:blogger.com,1999:blog-1386591855300347068.post-80386602276684178362012-06-19T11:25:00.001-04:002012-06-19T11:25:30.463-04:00A Trend Continues...<br />
<div class="MsoNormal">
With its <a href="http://www.cirm.ca.gov/PressRelease_2012-05-24">recent round of grants</a>,
the California Institute for Regenerative Medicine (CIRM) <a href="http://stemcellsthatwork.blogspot.com/2011/09/actions-speak-louder-than-words.html">continues a trend</a> begun
several years ago now – increasing support for non-embryonic stem cell research
and reducing support for destructive human embryonic stem cell research (hESCR)
and research aimed at human cloning. This
trend by CIRM away from embryonic stem cell research is not driven by any
ethical concerns—CIRM continues to issue grants for hESCR, only on a far
smaller scale than originally envisaged.
CIRM was founded, after all, on the premise that it would give funding
priority to hESCR and cloning for research as those were considered the most
promising avenues for producing cures. </div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
But since 2004, when California voters approved a referendum
establishing CIRM, the evidence for the efficacy of adult stem cells to provide
therapeutic benefits for patients has continually increased, while the evidence
for human embryonic stem cells to do the same has decreased. CIRM, for instance, <a href="http://www.cirm.ca.gov/PressRelease_2011-11-14">approved a $25 million
loan</a><a href="http://www.blogger.com/blogger.g?blogID=1386591855300347068#_ftn1" name="_ftnref1" style="mso-footnote-id: ftn1;" title=""><span class="MsoFootnoteReference"><span class="MsoFootnoteReference"><span style="font-family: "Times New Roman"; font-size: 12pt;">[1]</span></span></span></a> to
Geron for that company’s now infamous clinical trial using hESCs to treat
spinal cord injury, only to see Geron cancel the trial just over one year after
the first patient was treated -- with no evidence of therapeutic benefits to
the five patients who received the hESCs (see previous blog, <a href="http://stemcellsthatwork.blogspot.com/2011/12/era-ends-before-it-even-begins_08.html">“An Era EndsBefore It Even Begins”</a>). </div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
According to a report in <i style="mso-bidi-font-style: normal;"><a href="http://blogs.nature.com/news/2012/05/california-stem-cell-agency-shifts-toward-clinical-work.html">Nature</a></i>,
since October 2011 CIRM has been considering a new 5 year strategic plan that
gives funding priority to stem cell research with the best chance of leading to
clinical trials. The new plan, adopted
in late May, envisions at least 10 early stage clinical trials within the next
5 years.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Commenting on the shift of emphasis from basic research to
preparing for clinical trails, </div>
<div class="MsoNormal">
Deepak Srivastava, a cardiovascular researcher at the
Gladstone Institute in San Francisco,
told <i style="mso-bidi-font-style: normal;">Nature</i> “With their stated goals
of getting cures into people, it’s appropriate to shift the balance.”</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
The latest round of CIRM grants, announced the same day the
new strategic plan was adopted, reflects this funding priority of “getting
cures to people.” Of the 21 grants –totaling $69.3 million – only 6 involve
research using hESCs<a href="http://www.blogger.com/blogger.g?blogID=1386591855300347068#_ftn2" name="_ftnref2" style="mso-footnote-id: ftn2;" title=""><span class="MsoFootnoteReference"><span class="MsoFootnoteReference"><span style="font-family: "Times New Roman"; font-size: 12pt;">[2]</span></span></span></a> None of the grants go to human cloning for
research. </div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
The remaining 15 grants all go to research using adult stem
cells, iPSCs and direct reprogramming of adult cells. Obviously this funding emphasis -- a lion’s
share of $50.9 million --on non-embryonic research reflects a belief that these
avenues hold the most promise for producing actual therapies.</div>
<div style="mso-element: footnote-list;">
<br />
<hr align="left" size="1" width="33%" />
<div id="ftn1" style="mso-element: footnote;">
<div class="MsoFootnoteText">
<a href="http://www.blogger.com/blogger.g?blogID=1386591855300347068#_ftnref1" name="_ftn1" style="mso-footnote-id: ftn1;" title=""><span class="MsoFootnoteReference"><span class="MsoFootnoteReference"><span style="font-family: "Times New Roman"; font-size: 10pt;">[1]</span></span></span></a> Of the$25
million approved, Geron actually received $6.42 million before cancelling the
trial. The company has repaid the loan
in full, with interest. </div>
</div>
<div id="ftn2" style="mso-element: footnote;">
<div class="MsoNormal">
<a href="http://www.blogger.com/blogger.g?blogID=1386591855300347068#_ftnref2" name="_ftn2" style="mso-footnote-id: ftn2;" title=""><span class="MsoFootnoteReference"><span class="MsoFootnoteReference"><span style="font-family: "Times New Roman"; font-size: 12pt;">[2]</span></span></span></a> <span style="font-size: 10pt;">One of those six uses [non-embryonic] induced
pluripotent stem cells (iPSCs) in addition to hESCs.</span></div>
<div class="MsoFootnoteText">
<br /></div>
</div>
</div>DNHhttp://www.blogger.com/profile/09946127168836977549noreply@blogger.comtag:blogger.com,1999:blog-1386591855300347068.post-60055380074066668182012-04-12T16:24:00.000-04:002012-08-31T12:58:48.308-04:00Caveat emptor<!--[if gte mso 9]><xml> <w:WordDocument> <w:View>Normal</w:View> <w:Zoom>0</w:Zoom> <w:PunctuationKerning/> <w:ValidateAgainstSchemas/> <w:SaveIfXMLInvalid>false</w:SaveIfXMLInvalid> <w:IgnoreMixedContent>false</w:IgnoreMixedContent> <w:AlwaysShowPlaceholderText>false</w:AlwaysShowPlaceholderText> <w:Compatibility> <w:BreakWrappedTables/> <w:SnapToGridInCell/> <w:WrapTextWithPunct/> <w:UseAsianBreakRules/> <w:DontGrowAutofit/> </w:Compatibility> <w:BrowserLevel>MicrosoftInternetExplorer4</w:BrowserLevel> </w:WordDocument> </xml><![endif]--><!--[if gte mso 9]><xml> <w:LatentStyles DefLockedState="false" LatentStyleCount="156"> </w:LatentStyles> </xml><![endif]--><!--[if !mso]><img src="http://img2.blogblog.com/img/video_object.png" style="background-color: #b2b2b2; " class="BLOGGER-object-element tr_noresize tr_placeholder" id="ieooui" data-original-id="ieooui" /> <style>
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<div class="MsoNormal">
A recent <a href="http://hosted2.ap.org/APDEFAULT/bbd825583c8542898e6fa7d440b9febc/Article_2012-03-18-California%20Stem%20Cell/id-d9d69c6f689e4699839b53610d861030">AP report</a> looks at the California Institute for Regenerative Medicine (CIRM) halfway through its ten year term and asks “is it still relevant?”</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
The report bluntly notes:</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal" style="margin-left: .5in;">
“The taxpayer-funded institute wielded the extraordinary power to dole out $3 billion in bond proceeds to fund embryonic stem cell work with an eye toward treatments for a host of crippling diseases. Midway through its mission, with several high-tech labs constructed, but little to show on the medicine front beyond basic research, the California Institute for Regenerative Medicine faces an uncertain future…will it still exist when the money dries up?</div>
<div class="MsoNormal" style="margin-left: .5in;">
<br /></div>
<div class="MsoNormal">
This is in marked contrast to the very rosy predictions that were made in order to sell the institute to California voters in 2004.<span style="mso-spacerun: yes;"> </span>Back then, in order to convince voters to approve the establishment of CIRM in Proposition 71 -- <span style="mso-spacerun: yes;"> </span>at a cost of $3 billion over 10 years, plus interest -- <span style="mso-spacerun: yes;"> </span>proponents of the measure assured them that not only would human embryonic stem cell research (hESCR) produce all kinds of cures, but those cures would dramatically reduce the state’s healthcare costs and generate substantial royalties for the state.<span style="mso-spacerun: yes;"> </span>A <a href="http://digital.library.ucla.edu/websites/2004_996_027/economic_study.php.htm">report</a> by Stanford University confidently predicted that the research (primarily hESCR) supported by the institute would generate in royalties anywhere between $537 million to $1.1 billion.<span style="mso-spacerun: yes;"> </span>Overall, the report predicted a 120 to 236 percent return on the initial investment. </div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
That hasn’t happened and in all likelihood never will. Instead, the money is drying up and CIRM is looking for ways to raise more.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
The AP report goes on to ask, “So what have Californians received for their money so far?”<span style="mso-spacerun: yes;"> </span>The answer: “The most visible investment is the opening of sleek buildings and gleaming labs at a dozen private and public universities built with matching funds. Two years ago, Stanford University unveiled the nation's largest space dedicated to stem cell research: 200,000 square feet that can hold 550 researchers.”</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
And what about all the confidently predicted cures?<span style="mso-spacerun: yes;"> </span>“There are no cures yet in the pipeline and CIRM has shifted focus, channeling money to projects with the most promise of yielding near-term results.”</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Do No Harm has noted before at this blog spot that over the years, CIRM has increasingly moved away from its initial commitment to favor hESCR in awarding grants and toward adult stem cell research – precisely because such research is proving to have “the most promise of yielding near-term results.”</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
John Simpson of Consumer Watchdog told AP that CIRM is a victim of its early supporters' hype.<span style="mso-spacerun: yes;"> </span>“‘The impression you got was, if you just passed this bond measure, Christopher Reeve will be jumping out of his wheelchair and walking next week,’” said Simpson, referring to the late paralyzed actor who appeared in TV ads backing Prop 71. "They're having to live down the super high expectations that they raised."</div>
<div class="MsoNormal">
That hype, however, was necessary to sell such ethically contentious research to the public precisely because it was ethically contentious – hESCR necessarily requires the destruction of human life to proceed.<span style="mso-spacerun: yes;"> </span>Caveat emptor.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
There is an old adage we all heard from our parents and which we still tell our children today: “If it seems too good to be true, it probably is.”</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Regarding hESCR, California’s taxpayers are learning that lesson all over again. </div>
<div class="MsoNormal">
<br /></div>
DNHhttp://www.blogger.com/profile/09946127168836977549noreply@blogger.comtag:blogger.com,1999:blog-1386591855300347068.post-31209553596594878962011-12-08T17:09:00.000-05:002011-12-08T17:09:30.317-05:00An Era Ends Before It Even Begins<link href="file:///C:%5CUsers%5CGene%5CAppData%5CLocal%5CTemp%5Cmsohtml1%5C01%5Cclip_filelist.xml" rel="File-List"></link><o:smarttagtype name="PlaceType" namespaceuri="urn:schemas-microsoft-com:office:smarttags"></o:smarttagtype><o:smarttagtype name="PlaceName" namespaceuri="urn:schemas-microsoft-com:office:smarttags"></o:smarttagtype><o:smarttagtype name="country-region" namespaceuri="urn:schemas-microsoft-com:office:smarttags"></o:smarttagtype><o:smarttagtype name="State" namespaceuri="urn:schemas-microsoft-com:office:smarttags"></o:smarttagtype><o:smarttagtype name="City" namespaceuri="urn:schemas-microsoft-com:office:smarttags"></o:smarttagtype><o:smarttagtype name="place" namespaceuri="urn:schemas-microsoft-com:office:smarttags"></o:smarttagtype><style>
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</style> <![endif]--> <div class="MsoNormal">To paraphrase an oft-cited verse of T.S. Eliot’s, “this is the way the experiment ends.<span> </span>Not with a bang but a whimper.”</div><div class="MsoNormal"><br />
</div><div class="MsoNormal">The experiment was Geron’s highly touted clinical trial using human embryonic stem cells (hESCs) to treat patients with spinal cord injury (sci), for which the <a href="http://www.geron.com/media/pressview.aspx?id=1148">FDA gave approval</a> in January, 2009.<span> </span>The experiment certainly began with a bang, arriving with the usual media hype that human embryonic stem cell research (hESCR) has enjoyed over the years.<span> </span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal">“<span class="verdana">Some people think this is the dawn of a new era,” ABC’s Diane Sawyer gushed on <i>Good Morning America</i>.<span> </span>The <i>Los Angeles Times</i> agreed with Sawyer’s talking points, <a href="http://articles.latimes.com/2009/jan/24/science/sci-stemcells24">similarly gushing</a> that the trial was “ushering in a new era in medicine.”<span> </span><o:p></o:p></span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal"><span class="verdana">Well, that “new era” in medicine lasted not quite two years, which must be some sort of record for brevity in defining an “era.”<span> </span>On November 14<sup>th</sup> of this year, Geron announced it was shutting down its human embryonic stem cell program.<span> </span>During this brief “era,” 5 sci patients received infusions of hESCs (Geron originally intended to treat 10 patients total for the trial). <span> </span>While there were no serious adverse side effects, there has been no evidence of any benefits to the patients either.<span> </span><o:p></o:p></span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal"><span class="verdana">Geron cited <a href="http://www.geron.com/media/pressview.aspx?id=1284">financial difficulties</a> as the reason for shutting down the program.<span> </span>So how did market watchers react to that?<o:p></o:p></span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal"><span class="verdana">The Street.Com reacted by selecting Geron’s announcement to terminate its hESCR <span> </span>program as one of the <a href="http://www.thestreet.com/story/11313721/3/the-five-dumbest-things-on-wall-street-this-week-nov-18.html">“Five Dumbest Things on Wall Street”</a> for the week of November 18.<span> </span>It deserves to be quoted in full:<o:p></o:p></span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal" style="margin-left: 0.5in;"><span class="bold">“3. Geron's Bluto Moment</span></div><div class="loose1" style="margin-left: 0.5in;">You think John "Bluto" Blutarsky from Animal House had it bad? He saw only seven years of college go down the drain. Biotech bust <span class="bold">Geron </span>squandered 21 years of shareholder hopes, dreams and dollars on a wasted education. Shares of Geron fell 21% to $1.74 Tuesday as a result of its decision to shut down its embryonic <a href="" name="ORIGHIT_2"></a><a href="" name="HIT_2"></a><span class="hit">stem</span> <span class="hit">cell</span> research program in order to focus on its experimental cancer drugs. John Scarlett, Geron's newly appointed CEO, insisted in interviews Monday that the company's decision to exit the <a href="" name="ORIGHIT_3"></a><a href="" name="HIT_3"></a><span class="hit">stem</span> <span class="hit">cell</span> business was not an indictment of the entire field but was more a company-specific business decision. Frankly, Scarlett, we don't give a damn how you spin it, but Geron will always be an embryonic <a href="" name="ORIGHIT_4"></a><a href="" name="HIT_4"></a><span class="hit">stem</span> <span class="hit">cell</span> company. For more than two decades, Geron has been sucking money from investors' wallets like a <st1:city w:st="on"><st1:place w:st="on">Hoover</st1:place></st1:city> vacuum with the sole intent of turning embryonic <a href="" name="ORIGHIT_5"></a><a href="" name="HIT_5"></a><span class="hit">stem</span> <span class="hit">cells</span> into new tissue or organs. And now you want to drop it like a bad habit? And after all that preaching about how this technology will help paraplegics walk, cure diseases like diabetes and Parkinson's and prevent heart attacks -- not to mention an accumulated deficit of nearly $700 million -- now you want to try something new? No way, dude! You can't simply change your major like an aimless college student trying to delay graduation. Your parents -- or in this case, your shareholders and investors -- deserve better. Not that they have seen much of a return on their money so far. To date, only four paralyzed patients have received injections of embryonic <a href="" name="ORIGHIT_6"></a><a href="" name="HIT_6"></a><span class="hit">stem</span> <span class="hit">cell</span>-derived nerve cells into their spinal cords. And while no safety problems have been reported, Scarlett admitted that there were "no signs" the <a href="" name="ORIGHIT_7"></a><a href="" name="HIT_7"></a><span class="hit">stem</span> <span class="hit">cell</span> therapy was helping patients either. Still, that's no reason to abandon hope and to change course after all these years of trying. Remember, Bluto spent all those years in a filthy, idiotic fraternity and then went on to become a member of the U.S. Senate. Wait, maybe that's not the best analogy. But you know what we mean.”</div><div class="loose1" style="margin-left: 0.5in;"><br />
</div><div class="MsoNormal"><span class="verdana">For years, Geron cynically manipulated investors with carefully timed but nonetheless deceptive media announcements that its hESC clinical trial for spinal cord injury was imminent.<span> </span>Here’s a partial chronology of how Geron did this, as compiled by DNH founding member David Prentice, PhD: </span></div><div class="MsoNormal"><span class="verdana"><br />
</span></div><div class="MsoNormal"><span class="verdana"></span></div><div class="MsoNormal"><span class="verdana"><o:p></o:p></span></div><span style="font-family: Arial; font-size: 10pt;"><a href="http://www.mult-sclerosis.org/news/Mar2002/GeronDrugAlternativesToStemCellCloning.html" title="blocked::http://www.mult-sclerosis.org/news/Mar2002/GeronDrugAlternativesToStemCellCloning.html">18 March 2002</a><br />
<st1:place w:st="on"><st1:placetype w:st="on">University</st1:placetype> of <st1:placename w:st="on">California</st1:placename></st1:place>, Irvine Prof. Hans Keirstead announces he will ask university officials to seek the U.S. Food and Drug Administration's approval to test human embryonic stem cells on human patients with spinal cord injuries. Initially, Keirstead said he might be ready to take this step <strong><span style="font-family: Arial;">in about a year</span></strong>.<o:p></o:p></span><br />
<span style="font-family: Arial; font-size: 10pt;"><a href="http://seattletimes.nwsource.com/html/businesstechnology/2001862747_stemcells22.html" title="blocked::http://seattletimes.nwsource.com/html/businesstechnology/2001862747_stemcells22.html">22 February 2004</a><br />
"The company believes it will be cleared to start the first stem-cell therapy in human tests <strong><span style="font-family: Arial;">next year</span></strong>, possibly for spinal-cord injury."<o:p></o:p></span><br />
<span style="font-family: Arial; font-size: 10pt;"><a href="http://www.reason.com/news/show/34942.html" title="blocked::http://www.reason.com/news/show/34942.html">1 December 2004</a><br />
According to Geron CEO Thomas Okarma, the company is aiming to file an investigational new drug application with the U.S. Food and Drug Administration (FDA) requesting permission to begin clinical trials using glial cells derived from embryonic stem cells to repair damaged spinal cords <strong><span style="font-family: Arial;">in 2005 or early 2006</span></strong>.<o:p></o:p></span><br />
<span style="font-family: Arial; font-size: 10pt;"><a href="http://www.nytimes.com/2005/02/24/health/24iht-stem.html" title="blocked::http://www.nytimes.com/2005/02/24/health/24iht-stem.html">5 February 2005</a><br />
"<strong><span style="font-family: Arial;">Next year</span></strong> [Hans Keirstead] and his corporate partner, Geron, plan to try treating people who have recent spinal cord injuries, in what would almost certainly be the first human trial of any therapy derived from such cells.<o:p></o:p></span><br />
<span style="font-family: Arial; font-size: 10pt;"><a href="http://www.wired.com/medtech/health/news/2005/04/67266" title="blocked::http://www.wired.com/medtech/health/news/2005/04/67266">19 April 2005</a><br />
Thomas Okarma, Geron's CEO, is even less convinced that larger animal studies are necessary before testing Keirstead's technique in humans. During an interview at a conference, he said he believes <strong><span style="font-family: Arial;">the clinical trial could begin in mid-2006</span></strong>.<o:p></o:p></span><br />
<span style="font-family: Arial; font-size: 10pt;"><a href="http://www.nmsresearch.com/BioTech/BIO008-0909052.htm" title="blocked::http://www.nmsresearch.com/BioTech/BIO008-0909052.htm">9 September 2005</a><br />
"Geron plans to begin clinical trials on acute spinal cord injury treatment <strong><span style="font-family: Arial;">in early 2006</span></strong>, according to chief executive officer Tom Okarma."<o:p></o:p></span><br />
<span style="font-family: Arial; font-size: 10pt;"><a href="http://www.disabled.gr/lib/?p=8831" title="blocked::http://www.disabled.gr/lib/?p=8831">7 November 2005</a><br />
"[R]esearchers at Geron of Menlo Park want to take the next step - in people. They hope to get federal permission to inject those cells into damaged spinal cords. The procedure - which Geron <strong><span style="font-family: Arial;">intends to do next year</span></strong> - would be the first human tests of a treatment derived from human embryonic stem cells, the highly versatile body cells that can be coaxed into becoming almost any tissue in the body."<o:p></o:p></span><br />
<span style="font-family: Arial; font-size: 10pt;"><a href="http://www.wired.com/medtech/health/news/2006/03/70521" title="blocked::http://www.wired.com/medtech/health/news/2006/03/70521">29 March 2006</a><br />
Tom Okarma: We will complete our IND-enabling studies, which are now in process and still on track, and file our IND during the fourth quarter of this year, assuming the preclinical data continue to go well. That starts a 30-day review clock by the FDA, who then has 30 days to either accept our <st1:state w:st="on"><st1:place w:st="on">IND</st1:place></st1:state> and allow us to proceed or, at that point, they have questions that we must answer before we can begin. We are on track for that. So, assuming they bless the <st1:state w:st="on"><st1:place w:st="on">IND</st1:place></st1:state>, we would hope to be <strong><span style="font-family: Arial;">in the clinic in the first quarter of (2007)</span></strong>.<o:p></o:p></span><br />
<span style="font-family: Arial; font-size: 10pt;"><a href="http://www.newscientist.com/article/dn9349" title="blocked::http://www.newscientist.com/article/dn9349">17 June 2006</a><br />
"<strong><span style="font-family: Arial;">I'm confident that we will be in the clinic next year</span></strong> with the first human ESC-derived product," said Tom Okarma, chief executive of Geron, at a conference in London last week.<o:p></o:p></span><br />
<span style="font-family: Arial; font-size: 10pt;"><a href="http://www.nature.com/nature/journal/v442/n7101/full/442336a.html" title="blocked::http://www.nature.com/nature/journal/v442/n7101/full/442336a.html">27 July 2006</a><br />
The company will apply for approval to <strong><span style="font-family: Arial;">start US clinical trials in 2007</span></strong>, using glial cells derived from human embryonic stem cells to treat spinal injuries.<o:p></o:p></span><br />
<span style="font-family: Arial; font-size: 10pt;"><a href="http://www.technologyreview.com/read_article.aspx?ch=specialsections&sc=stemcell&id=17256" title="blocked::http://www.technologyreview.com/read_article.aspx?ch=specialsections&sc=stemcell&id=17256">4 August 2006</a><br />
One company, in particular, Menlo Park, CA-based Geron, is taking the lead in developing experimental embryonic stem cell therapies and hopes to begin human trials <strong><span style="font-family: Arial;">next year</span></strong>.<o:p></o:p></span><br />
<span style="font-family: Arial; font-size: 10pt;"><a href="http://www.ft.com/cms/s/85d1e6f8-fe1f-11db-bdc7-000b5df10621.html" title="blocked::http://www.ft.com/cms/s/85d1e6f8-fe1f-11db-bdc7-000b5df10621.html">9 May 2007</a><br />
"The first clinical trial of embryonic stem cells is on track to <strong><span style="font-family: Arial;">start early next year</span></strong> on patients with spinal cord injury. Geron, the California-based biotechnology company, will carry out the study on accident victims in six trauma centres across the <st1:country-region w:st="on"><st1:place w:st="on">US</st1:place></st1:country-region>."<o:p></o:p></span><br />
<span style="font-family: Arial; font-size: 10pt;"><a href="http://www.sciencemag.org/cgi/content/summary/317/5836/305" title="blocked::http://www.sciencemag.org/cgi/content/summary/317/5836/305">20 July 2007</a><br />
"Geron Corporation in Menlo Park, California, expects to start clinical trials of a therapy for spinal cord injury <strong><span style="font-family: Arial;">early in 2008</span></strong>, according to spokesperson David Schull."<o:p></o:p></span><br />
<span style="font-family: Arial; font-size: 10pt;"><a href="http://money.cnn.com/2007/10/31/news/companies/stem_cells/" title="blocked::http://money.cnn.com/2007/10/31/news/companies/stem_cells/">31 October 2007</a><br />
Geron, based in <st1:place w:st="on"><st1:city w:st="on">Menlo Park</st1:city>, <st1:state w:st="on">Calif.</st1:state></st1:place>, has been using rats in its experiments of a potential treatment for spinal cord injuries. Geron has already met with the FDA and will submit its plans for human testing to the agency <strong><span style="font-family: Arial;">by the end of this year</span></strong>, according to Sion.<o:p></o:p></span><br />
<span style="font-family: Arial; font-size: 10pt;"><a href="http://www.geron.com/media/pressview.aspx?id=1104" title="blocked::http://www.geron.com/media/pressview.aspx?id=1104">13 November 2007</a><br />
Geron's development plan for the product calls for the filing of an Investigational New Drug (IND) Application with the U.S. Food and Drug Administration and, pending the agency's review, <strong><span style="font-family: Arial;">initiation of human clinical trials in 2008</span></strong>.<o:p></o:p></span><br />
<span style="font-family: Arial; font-size: 10pt;"><a href="http://www.geron.com/media/pressview.aspx?id=1104" title="blocked::http://www.geron.com/media/pressview.aspx?id=1104">13 November 2007</a><br />
Geron's development plan for the product calls for the filing of an Investigational New Drug (IND) Application with the U.S. Food and Drug Administration and, pending the agency's review, <strong><span style="font-family: Arial;">initiation of human clinical trials in 2008</span></strong>.<o:p></o:p></span><br />
<div style="margin: 0in 0in 0.0001pt;"><span style="font-family: Arial; font-size: 10pt;"><a href="http://www.nytimes.com/2008/05/15/business/15stem.html" title="blocked::http://www.nytimes.com/2008/05/15/business/15stem.html">15 May 2008</a><br />
The Geron Corporation announced Wednesday that its plans to begin the first clinical trial using embryonic stem cells had been delayed by federal regulators. While companies typically do not announce when they submit an application to begin a trial for an investigational new drug, the F.D.A.'s action means Geron <strong><span style="font-family: Arial;">must have submitted its application in the last 30 days</span></strong>, Mr. Benjamin said.<br />
<!--[endif]--><o:p></o:p></span></div><div style="margin: 0in 0in 0.0001pt;"><span style="font-family: Arial; font-size: 10pt;"><a href="http://www.the-scientist.com/blog/display/55096/" title="blocked::http://www.the-scientist.com/blog/display/55096/">17 October 2008</a><br />
But the FDA is nearing the end of its review process and may lift the hold and allow clinical trials to commence <strong><span style="font-family: Arial;">within the next three months</span></strong>, Okarma told <i>The Scientist</i>.<o:p></o:p></span></div><span style="font-family: Arial; font-size: 10pt;"><a href="http://www.scientificamerican.com/blog/60-second-science/post.cfm?id=spinal-cord-stem-cell-trial-could-s-2008-10-20" title="blocked::http://www.scientificamerican.com/blog/60-second-science/post.cfm?id=spinal-cord-stem-cell-trial-could-s-2008-10-20">20 October 2008</a><br />
A clinical trial that would test the use of embryonic stem cells to treat spinal cord injury could begin <strong><span style="font-family: Arial;">within three months</span></strong>.<o:p></o:p></span><br />
<div class="MsoNormal"><br />
</div><div class="MsoNormal">In sum, Geron’s behavior over the years is emblematic of the way hESCR proponents have tried to advance their cause: year after year after year, promise major medical breakthroughs with, in the end, little or nothing to show for it.<span> </span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal"><span class="verdana">In addition to the market, other observers saw other forces at play in the demise of Geron’s hESC trial.<span> </span>According to <i>Datamonitor Expert View</i>: “</span>Although many would say that Geron's decision reflects the worsening economic environment, in which biotechnology companies are increasingly struggling to raise capital investment, Datamonitor believes that the underlying reasons for the announced divestment actually relate to clinical and intellectual property roadblocks facing Geron's stem cell programs... Geron's divestment highlights the <a href="http://www.datamonitor.com/store/News/geron_runs_out_of_steam_while_others_race_ahead?productid=DE37FA58-BC0B-487E-B8A6-23CD604C2BE4">potential pitfalls associated with specific types of stem cell technologies - <i>namely, embryonic stem cells</i></a> (emphasis added).”</div><div class="MsoNormal"><br />
</div><div class="MsoNormal">In marked contrast, Datamonitor went on to observe, “adult stem cell therapies continue to race ahead.”<span> </span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal">As Geron’s great new era of medicine was closing with a (media) whimper, the Discovery Institute’s Wesley Smith noted the media’s double standard in the way it covered Geron’s failure vs. advances with adult stem cells.</div><div class="MsoNormal"><br />
</div><div class="MsoNormal"><a href="http://www.weeklystandard.com/author/wesley-j.-smith">“You would think Geron’s failure would be very big news,”</a> Smith wrote in the <i>Weekly Standard</i>.<span> </span>“Instead, it turns out that the mainstream media pay attention only when embryonic stem cell research seems to be succeeding—so far, almost exclusively in animal studies.<span> </span>When, as here, it crashes and burns, it is scarcely news at all.”</div><div class="MsoNormal"><br />
</div><div class="MsoNormal">Citing, for example, the attention the <i>Los Angeles Times</i> gave to the FDA’s approval of the Geron trial in January 2009, and then again when the first patient actually received a transfusion of hESCs in October, 2010, Smith noted: “During the same period, however, the paper did not report the encouraging results of early human trials of treatments for spinal cord injury developed using adult stem cells.”</div><div class="MsoNormal">On that <i>Good Morning America</i> show cited above, Sawyer asked Sean Morrison, PhD, a researcher at the Howard Hughes Medical Institute: “What about it, Dr. Morrison? Do you think it could have been done with adult stem cells?”</div><div class="MsoNormal">Morrison replied: I don't think there's any adult stem cell that's ready for use in clinical trials that could be used to do what <span class="hit">Geron</span> is doing with these [embryonic] cells.”</div><div class="MsoNormal"><br />
</div><div class="MsoNormal"><span class="verdana">How to explain such a remark?<span> </span><span> </span>Ignorance?<span> </span>A willingness to mislead?<o:p></o:p></span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal"><span class="verdana">In 2005 – four years before the FDA approved Geron’s trial – Dr. Carlos Lima of Portugal published a report in the peer-reviewed <i><a href="http://physicians.ascipro.org/pdf/olfactory.pdf">Journal of Spinal Cord Medicine</a> </i>showing positive results from a “pilot clinical study” that used adult stem cells derived from olfactory mucosa to treat sci patients<span> </span>(Lima subsequently published a second study on the use of olfactory mucosa derived stem cells to treat sci patents in the peer-reviewed <a href="http://nnr.sagepub.com/content/24/1/10">Neurorehabilitation and Neural Repair</a>, 9/30/09).<span> </span><o:p></o:p></span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal">Even earlier, in 2002, reviewing the positive results of using such stem cells in animal models, the Federation of American Societies for Experimental Biology declared : “These results are the most <a href="http://www.sciencedaily.com/releases/2002/04/020424073621.htm">dramatic functional and histological repair yet achieved after complete spinal cord transaction in mammals</a>, and they open new avenues in the search for treatment of spinal cord injuries in other mammals, including humans<b>.”</b></div><div class="MsoNormal"><br />
</div><div class="MsoNormal">Finally, and perhaps most important, a word about the patients.<span> </span>They are the ones who have been the most ill-served by all the media hype surrounding Geron’s “new era” of medicine and hESCR in general.<span> </span>They have also been ill served by the corresponding willingness of the media and even many researchers to downplay the very real and ongoing advances with adult stem cells.<span> </span><span> </span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal">There is still great hope and promise for stem cell research to help patients.<span> </span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal">As the Geron example shows, don’t go looking for human embryonic stem cell research to fulfill it.<span> </span>That hope and promise are being realized with adult stem cells. <span class="verdana"><o:p></o:p></span></div><div class="MsoNormal"><br />
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</div>DNHhttp://www.blogger.com/profile/09946127168836977549noreply@blogger.comtag:blogger.com,1999:blog-1386591855300347068.post-5017804407986770722011-11-21T14:20:00.000-05:002011-11-21T14:20:47.158-05:00Simpler, Better<link href="file:///C:%5CUsers%5CGene%5CAppData%5CLocal%5CTemp%5Cmsohtml1%5C01%5Cclip_filelist.xml" rel="File-List"></link><!--[if gte mso 9]><xml> <w:WordDocument> <w:View>Normal</w:View> <w:Zoom>0</w:Zoom> <w:PunctuationKerning/> <w:ValidateAgainstSchemas/> <w:SaveIfXMLInvalid>false</w:SaveIfXMLInvalid> <w:IgnoreMixedContent>false</w:IgnoreMixedContent> <w:AlwaysShowPlaceholderText>false</w:AlwaysShowPlaceholderText> <w:Compatibility> <w:BreakWrappedTables/> <w:SnapToGridInCell/> <w:WrapTextWithPunct/> <w:UseAsianBreakRules/> <w:DontGrowAutofit/> </w:Compatibility> <w:BrowserLevel>MicrosoftInternetExplorer4</w:BrowserLevel> </w:WordDocument> </xml><![endif]--><!--[if gte mso 9]><xml> <w:LatentStyles DefLockedState="false" LatentStyleCount="156"> </w:LatentStyles> </xml><![endif]--><style>
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</style> <![endif]--><div class="MsoNormal"><i>The New Scientist</i> recently ran a rather remarkable editorial, <a href="http://www.newscientist.com/article/mg21228343.200-in-praise-of-stemcell-simplicity.html">“In praise of stem cell simplicity.”</a></div><div class="MsoNormal"><br />
</div><div class="MsoNormal"><span>“We should keep all avenues of stem-cell research open but be grateful when simpler alternatives emerge,” the editorial asserts.<span> </span>Pointing to recent advances using adult and induced pluripotent stem cells (iPSCs), the article says these “</span>could spawn novel, personalized stem-cell treatments that, if not simple per se, are simpler than what has gone before.”</div><div class="MsoNormal"><br />
</div><div class="MsoNormal">Not only are these advances simpler (compared to using human embryonic stem cells (hESCs) to try and treat disease), but “[w]hat marks these treatments out is that they are eminently practical and ethically unquestionable. This is in stark contrast to much previous work, which has focused on human embryonic stem cells, or hESCs.”</div><div class="MsoNormal"><br />
</div><div class="MsoNormal">Drawing out that contrast, the article notes that hESC research has always been ethically questionable.<span> </span>It then refers to the so-called “breakthrough” in October using cloning to produce human stem cells.<span> </span>However, the article notes, the process still required eggs, an embryo was still killed and the resulting stem cells were genetically malformed, “rendering them useless for medical uses.”<span> </span>Three strikes and that so-called breakthrough is out.</div><div class="MsoNormal"><br />
</div><div class="MsoNormal">The article specifically refers to two advances demonstrating how non-embryonic stem cell research is simpler than and superior to hESCR.<span> </span>“<a href="http://www.newscientist.com/article/dn21019-diabetic-rats-cured-with-their-own-stem-cells.html">Diabetic rats cured</a> with their own stem cells” tells how researchers transformed brain stem cells that had been extracted through the nose into insulin producing cells in the pancreas.”<span> </span>The researchers did this “without genetic trickery.”</div><div class="MsoNormal"><br />
</div><div class="MsoNormal">The second advance tells how scientists used <a href="http://www.newscientist.com/article/mg21228344.400-baby-repair-kit-found-inside-the-womb.html">stem cells taken from a baby’s own amniotic fluid to repair congenital defects</a> such as holes in the diaphragm.</div><div class="MsoNormal"><br />
</div><div class="MsoNormal">So it would certainly appear clear that non-embryonic approaches to stem cell research are turning out to be simpler and more effective in terms of actually producing therapies than hESCR. <span> </span>Despite these advantages, however, the article concludes by calling for all avenues of stem cell research to continue.<span> </span>For instance, the article notes, iPSCs are reprogrammed using a virus and the reprogrammed cells do not yet match embryonic stem cells.</div><div class="MsoNormal"><br />
</div><div class="MsoNormal">However, the process of producing iPSCs has vastly improved in the relatively short time since they were first discovered in 2007.<span> </span>Researchers have used a particular RNA viral vector that carries no risk of integrating into the host genome, to produce <a href="http://www.pnas.org/content/early/2011/08/04/1103509108">iPSCs that have no foreign gene insertions and that are viral/factor-free.</a><span> </span>The researchers reported that “the resulting iPSCs expressed human embryonic stem cell markers and exhibited pluripotency.” <span> </span>Another study has found that proteins produced by iPSCs and human embryonic stem cells (hESCs) are 99 percent similar.<span> </span>According to one of the researchers the study suggests that iPSCs and hESCs are quite similar<u>.<span> </span><a href="http://www.news.wisc.edu/19744">“According to some measurements, the protein production of an embryonic stem cell was closer to that of an IPS cell than to a second embryonic stem cell. “</a></u></div><div class="MsoNormal"><br />
</div><div class="MsoNormal">As the Do No Harm Coalition has frequently pointed out, in 1999, when President Clinton’s National Bioethics Advisory Committee (NBAC) first recommended federal funding for hESCR,<a href="http://bioethics.georgetown.edu/nbac/stemcell.pdf"> it did so conditionally</a>: “In our judgment, the derivation of stem cells from embryos remaining following infertility treatments is justifiable only if no less morally problematic alternatives are available for advancing the research…The claim that there are alternatives to using stem cells derived from embryos is not, at the present time, supported scientifically. <i>We recognize, however, that this is a matter that must be revisited continually as science advances.” </i>(<i>Ethical Issues in Human Stem Cell Research, </i>Volume I, p.53, emphasis added). </div><pre><span style="font-family: "Times New Roman"; font-size: 12pt;"><o:p> </o:p></span></pre><div class="MsoNormal">In other words, they recognized that, given the ethical problems associated with hESCR, it should not be undertaken if viable alternatives exist. <span> </span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal">Such viable alternatives exist.<span> </span>Advances in non-hESCR to treat disease are many, ongoing and well documented in the peer-reviewed literature.<span> </span>It’s time that proponents of human embryonic stem cell research revisit, in the light of scientific advances, their earlier premature judgments on the need to pursue such destructive research.</div>DNHhttp://www.blogger.com/profile/09946127168836977549noreply@blogger.comtag:blogger.com,1999:blog-1386591855300347068.post-9134827266297160142011-11-02T13:12:00.000-04:002015-05-29T16:37:59.767-04:00Are they really still bothering with That?<link href="file:///C:%5CUsers%5CGene%5CAppData%5CLocal%5CTemp%5Cmsohtml1%5C01%5Cclip_filelist.xml" rel="File-List"></link><o:smarttagtype name="PlaceType" namespaceuri="urn:schemas-microsoft-com:office:smarttags"></o:smarttagtype><o:smarttagtype name="PlaceName" namespaceuri="urn:schemas-microsoft-com:office:smarttags"></o:smarttagtype><o:smarttagtype name="City" namespaceuri="urn:schemas-microsoft-com:office:smarttags"></o:smarttagtype><o:smarttagtype name="place" namespaceuri="urn:schemas-microsoft-com:office:smarttags"></o:smarttagtype><style>
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In 2007, the world was introduced to <a href="http://www.stemcellresearch.org/commentary/answeringcommonclaims.htm">induced pluripotent stem cells</a> (iPSCs).</div>
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With this breakthrough, Somatic Cell Nuclear Transfer (SCNT) -- more commonly known as cloning -- suddenly looked to be the Dodo bird in the field of stem cell research and regenerative medicine.</div>
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But human cloning for research has staged a mini-comeback recently, attended by the usual media hype that always seems to accompany any development in embryo-destructive stem cell research. </div>
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In a 10/6/11 article published in <i><a href="http://www.nature.com/nature/journal/v478/n7367/full/nature10397.html">Nature,</a></i> scientists reported that they had, for the first time, successfully generated a line of stem cells from a cloned human embryo.</div>
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Numerous media outlets hailed the news as a “major breakthrough” for stem cell research that had, according to <a href="http://www.cbsnews.com/8301-504763_162-20116695-10391704.html?tag=mncol;lst;2">CBS</a>, “scientists buzzing.” “May lead to cure for Parkinson’s and diabetes” declared the (<st1:place w:st="on"><st1:city w:st="on">London</st1:city></st1:place>) <i><a href="http://www.independent.co.uk/life-style/health-and-families/health-news/stem-cell-breakthrough-may-lead-to-cure-for-parkinsons-and-diabetes-2366153.html">Independent<span style="font-style: normal;">.</span></a></i> </div>
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But for all the buzzing and talk of cures on the horizon, the stem cells harvested from the cloned embryo were therapeutically useless. Dr. Scott Noggle, co-author of the <i>Nature</i> article announcing the “breakthrough” admitted as much: <span class="verdana">"These cells <a href="http://www.nytimes.com/2011/10/06/science/06stem.html?_r=1&scp=1&sq=noggle&st=cse">are not therapeutically relevant</a> at the moment," he stated. The cells were, in fact, abnormal, given the way that Noggle and his colleagues carried out the SCNT procedure. <o:p></o:p></span></div>
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<span class="verdana">Typically, the SCNT procedure entails removing the nucleus from an egg, thus removing its genetic material. The nucleus from the donor’s somatic cell is then inserted into the enucleated egg and stimulated to begin development of the cloned embryo. This is the process used to create Dolly the sheep, but it has never been successful in producing a viable human embryo.<o:p></o:p></span></div>
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<span class="verdana">The success reported in <i>Nature</i> changed this procedure by inserting the nucleus of the donor’s somatic cell into an intact egg, i.e., an egg that still contained its nucleus. While viable (for purposes of harvesting stem cells) embryos were produced, because the egg’s nucleus was not removed the embryos were abnormal, as they contained an extra set of chromosomes, as did the stem cells harvested from those embryos. Thus, the cells could serve no therapeutic purpose. "These are <a href="http://www.washingtonpost.com/national/health-science/scientists-report-possibly-crucial-advance-in-human-embryonic-stem-cell-research/2011/09/28/gIQAWeYHOL_story_1.html">grotesquely abnormal cells</a>, so they have no clinical applications. Even scientifically they are of questionable value," said Maureen L. </span><a href="http://www.blogger.com/post-edit.g?blogID=1386591855300347068&postID=913482726629716014" name="ORIGHIT_2"></a><a href="http://www.blogger.com/post-edit.g?blogID=1386591855300347068&postID=913482726629716014" name="HIT_2"></a><span class="hit">Condic,</span><span class="verdana"> an associate professor of neurobiology and anatomy at the <st1:place w:st="on"><st1:placetype w:st="on">University</st1:placetype> of <st1:placename w:st="on">Utah</st1:placename></st1:place>.<o:p></o:p></span></div>
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<span class="verdana">In truth, news of this supposed “breakthrough” came across as tired and stale, especially in light of the fact that scientist are currently producing patient specific, fully pluripotent stem cells without having to create and destroy embryos -- <a href="http://www.stemcellresearch.org/commentary/answeringcommonclaims.htm">iPSCs</a> . <o:p></o:p></span></div>
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IPSCs are ordinary somatic cells, such as a skin cell, that have been reprogrammed into a fully pluripotent state, like an embryonic stem cell. Among the great benefits of this breakthrough in reprogramming cells is that it gives researchers a ready and virtually unlimited supply of pluripotent stem cells without having to destroy human embryos. Nor would women be subject to health risks and exploitation because of the large number of eggs necessary for research cloning.</div>
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Moreover, iPSCs are patient specific, i.e., they share the same genetic material with the donor of the reprogrammed somatic cell. For many, the ability to generate patient specific stem cells for transplant was the holy grail of stem cell research. The whole point behind cloning for research was to generate such cells by using SCNT to create an embryo that was the virtual genetic duplicate of the patient, and then destroy that embryo for his or her stem cells. </div>
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With the advent of iPSCs, cloning for research became all but obsolete. No less than Ian Wilmut, the scientist most associated with cloning for his role in creating Dolly the sheep, <a href="http://www.telegraph.co.uk/science/science-news/3314696/Dolly-creator-Prof-Ian-Wilmut-shuns-cloning.html">announced he was giving up on SCNT research</a> to pursue iPSC research instead. And the California Institute for Regenerative Medicine, established by voter referendum in 1997 with a 10 year, $3 billion budget and a mandate to give preferential funding to human embryonic stem cell research (hESCR), including cloning for research, has been noticeably stingy in grants given to the latter (in fact, the number of grants <a href="http://www.signonsandiego.com/news/2009/oct/29/sd-researchers-awarded-stem-cell-funds/">CIRM has given over the years to adult stem cell research</a> projects has proven greater than those for hESCR and SCNT). </div>
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No doubt the idea of cloning will continue to provide fodder for science fiction writers and their fans well into the future. And it will keep some researchers buzzing. </div>
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But the supposed potential of human cloning for research to be a practical, therapeutic tool to actually help treat patients, already seems like a thing of the past.</div>
DNHhttp://www.blogger.com/profile/09946127168836977549noreply@blogger.comtag:blogger.com,1999:blog-1386591855300347068.post-59396902996447198982011-09-23T14:52:00.005-04:002012-06-19T16:33:37.633-04:00Actions Speak Louder Than Words<link href="file:///C:%5CUsers%5CGene%5CAppData%5CLocal%5CTemp%5Cmsohtml1%5C01%5Cclip_filelist.xml" rel="File-List"></link><o:smarttagtype name="State" namespaceuri="urn:schemas-microsoft-com:office:smarttags"></o:smarttagtype><o:smarttagtype name="place" namespaceuri="urn:schemas-microsoft-com:office:smarttags"></o:smarttagtype><style>
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Late August saw another <a href="http://www.cirm.ca.gov/summaries-review-applications-rfa-10-05-disease-team-therapy-development-awards">round of grants</a> from the California Institute for Regenerative Medicine (CIRM).</div>
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CIRM, you may recall, was established by a voter-approved referendum in 2004, with a $3 billion budget (plus another $3 billion in interest) over 10 years. Its mission was to fund stem cell research, with funding preference to go to human embryonic stem cell research (hESCR) and to human cloning for research. </div>
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But as the late August grants (again) show, things have not turned out as anticipated. </div>
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This round of grants is intended to encourage researchers to form teams in an effort to quicken the time frame for translating research into actual clinical trials. As CIRM put it, the grants would encourage “the most promising <span class="verdana">approaches towards and into early phase clinical trials.”<o:p></o:p></span></div>
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<span class="verdana">So what are these “most promising approaches” to actually producing early phase clinical trials, especially in terms of CIRM’s mandate to give preferential treatment to hESCR and human cloning for research?<o:p></o:p></span></div>
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<span class="verdana">Well, projects involving adult stem cells were preferred over those utilizing embryonic stem cells – and by a whopping 3 to 1 margin. <o:p></o:p></span></div>
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<span class="verdana">In total, CIRM handed out 19 grants amounting to $1.8 million in preliminary funding (a second round of grants will be worth up to $20 million each). Of those 19, 16 involved the potential therapeutic uses of stem cells (other proposals addressed other research areas, such as proposals to study cancer stem cells). Of those 16, 12 involved proposals to use adult stem and other non-embryonic stem cells to treat heart disease, Huntington’s and Alzheimer’s, among others. Eleven will use actual adult stem cells, while 1 will use non-embryonic induced pluripotent stem cells (iPSCs). <o:p></o:p></span></div>
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<span class="verdana">Only 4 of the approved grants were for projects using hESCs. No grants were awarded to research using cloned human embryos.<o:p></o:p></span></div>
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<span class="verdana">This latest round of grants actually continues a pattern that has been developing for some time at CIRM. <o:p></o:p></span></div>
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<span class="verdana">In October, 2009, a major round of CIRM grants totaling some $230 million went to 14 research projects – but only 4 of them involved the use of hESCs. The rest, again, went to research using adult stem cells or more conventional approaches, such as drugs to treat cancer. <o:p></o:p></span></div>
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<span class="verdana">The irony of an institute founded to give preferential support to hESCR and human cloning for research instead giving such extensive support to adult stem cell research was not lost to observers at the time. <o:p></o:p></span></div>
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<span style="font-size: small;">“In something of an irony, little of it is going to the reason the institute exists - to work with human embryonic stem cells,” the <i><a href="http://ksjtracker.mit.edu/2009/10/29/nytimes-sf-chronicle-cp-california-stem-cell-institute-finally-handing-out-big-research-money-hardly-any-of-it-for-the-embryonic-variety-of-stem-cells/">Knight Science Journalism Tracker</a></i> commented. </span></div>
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<span style="font-size: small;">The <i><a href="http://www.signonsandiego.com/news/2009/oct/29/sd-researchers-awarded-stem-cell-funds/">San Diego Union-Tribune</a></i> noted: “One irony of the latest grants is that much of the work they support does not involve human embryonic stem cells, a contentious area because it requires the destruction of embryos. Bush administration funding restrictions on that work were a big reason the <st1:state w:st="on"><st1:place w:st="on">California</st1:place></st1:state> institute was launched to begin with, but many of the current projects use less-controversial adult stem cells”. </span></div>
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<span style="font-size: small;">And the <i><a href="http://www.nytimes.com/2009/10/29/health/research/29stem.html">New York Times</a></i> said that the large number of grants to adult stem cell research compared to embryonic is a “tacit acknowledgment that the promise of human embryonic stem cells is still far in the future.”</span></div>
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<span class="verdana">While CIRM’s favoring of adult stem cell research may be ironic, it is nonetheless understandable. <span style="color: black;">CIRM knows it needs to show some tangible results to <st1:state w:st="on"><st1:place w:st="on">California</st1:place></st1:state> taxpayers for what will eventually be their $6 billion investment in stem cell research. </span></span></div>
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<span class="verdana">Hype -- especially the hype over ESCR that played such a large role in CIRM’s creation – will only get you so far. And as it noted in handing out the current round of grants, CIRM gives priority to those project which seem the “most promising” to actually result in clinical trials. <o:p></o:p></span></div>
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<span class="verdana">Once again, adult stem research is proving the most promising approach toward achieving both these goals.<o:p></o:p></span></div>
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<span class="verdana">And the promise of hESCR still remains “far in the future.”<o:p></o:p></span></div>DNHhttp://www.blogger.com/profile/09946127168836977549noreply@blogger.comtag:blogger.com,1999:blog-1386591855300347068.post-46691171293116295952011-09-12T16:40:00.000-04:002011-09-12T16:40:36.301-04:00Scientific Sense and the Sense of Propriety<link href="file:///C:%5CUsers%5CGene%5CAppData%5CLocal%5CTemp%5Cmsohtml1%5C01%5Cclip_filelist.xml" rel="File-List"></link><!--[if gte mso 9]><xml> <w:WordDocument> <w:View>Normal</w:View> <w:Zoom>0</w:Zoom> <w:PunctuationKerning/> <w:ValidateAgainstSchemas/> <w:SaveIfXMLInvalid>false</w:SaveIfXMLInvalid> <w:IgnoreMixedContent>false</w:IgnoreMixedContent> <w:AlwaysShowPlaceholderText>false</w:AlwaysShowPlaceholderText> <w:Compatibility> <w:BreakWrappedTables/> <w:SnapToGridInCell/> <w:WrapTextWithPunct/> <w:UseAsianBreakRules/> <w:DontGrowAutofit/> </w:Compatibility> <w:BrowserLevel>MicrosoftInternetExplorer4</w:BrowserLevel> </w:WordDocument> </xml><![endif]--><!--[if gte mso 9]><xml> <w:LatentStyles DefLockedState="false" LatentStyleCount="156"> </w:LatentStyles> </xml><![endif]--><style>
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</style> <![endif]--> <div class="MsoNormal">A student who was doing a project on stem cell research emailed DNH a series of questions, one of which was “Is there any scientific reason to not continue with stem cell research?”</div><div class="MsoNormal"><br />
</div><div class="MsoNormal">It seems like a reasonable question, given that stem cell research – or, more correctly, human embryonic stem cell research (hESCR) -- <span> </span>is and remains very controversial.<span> </span>The controversy arises over the <i>ethics</i> of destroying human embryos for research, which is the necessary basis of hESCR.<span> </span>But, the questioner wanted to know, what about the <i>science</i>? Are there any <i>scientific</i> reasons for ending hESCR? </div><div class="MsoNormal"><br />
</div><div class="MsoNormal">After some thought though, it becomes clear that the student’s question is based on a misguided assumption, but one that nonetheless has underlined much of the debate over the propriety of pursuing hESCR.<span> </span>This assumption is that “science” is the ultimate arbiter of what “science” should or should not do.<span> </span>Throughout the national debate on hESCR we frequently heard the argument that we should be “guided by the science” in determining whether the research should receive federal funding, and that those outside the scientific community had no business telling scientists what they could or could not do.<span> </span>The ultimate logic of this assumption is that scientists should have the final say on what research projects to pursue, whatever – or in spite of— the ethical objections, however sound, other voices may raise.</div><div class="MsoNormal"><br />
</div><div class="MsoNormal">Which brings us to a fascinating article in the August issue of Wired: <a href="http://www.wired.com/magazine/2011/07/ff_swr/all/1">“Seven Creepy Experiments That Could Teach Us So Much (If They Weren’t So Wrong)</a>.<span> </span><span> </span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal">The title pretty much tells the story.<span> </span>The article highlights seven proposed experiments that -- <span> </span>from a purely scientific perspective -- <span> </span>would benefit us and add to our store of knowledge, but would not (at least at present) be undertaken because of the ethical objections they raise.<span> </span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal">For example, one experiment calls for testing potentially toxic substances in human subjects, rather than in animals.<span> </span>The benefits from such an experiment should be obvious – as should the ethical objections to it.<span> </span>Another experiment calls for inserting a “reporter” gene into an embryo in order to directly observe the process of how genes turn on and off and guide the development of the embryo from just a few cells into a fully differentiated human.<span> </span>“If ethics weren’t an issue” the author notes, the knowledge gained from such an experiment could provide a real boost to the field of regenerative medicine. <span> </span>Yet another experiment proposes to breed a human-chimpanzee hybrid.<span> </span>The experiment could help answer many questions surrounding evolution and the origins of humans.<span> </span>The late biologist Steven Jay Gould called such a proposal “the most potentially interesting and ethically unacceptable experiment I can imagine.”</div><div class="MsoNormal"><br />
</div><div class="MsoNormal">All of these proposed experiments are as scientifically sound as they are ethically unsound.<span> </span>All of them, from a purely scientific perspective, make sense, are designed to be carried out as efficiently and effectively as possible, and would add to our store of knowledge and even result in tangible benefits such as preventing and treating disease.<span> </span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal">So, if we were guided first and foremost by science, we would be doing these experiments.<span> </span>But because of the ethics, we do not.<span> </span>In other words, while science may be competent to tell us what we are able to do, and the most efficient way to do it, it is not within the competence of science to tell us what we should or should not do.<span> </span>That judgment must come from outside of science.<span> </span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal">The same is true for human embryonic stem cell research.<span> </span>Which is why the argument that we should let the “science” determine whether or not to pursue hESCR is so misleading and disingenuous.<span> </span>As the examples from <i>Wired</i> show, science can make no such determination; it can only come from disciplines outside of science. </div><div class="MsoNormal"><br />
</div><div class="MsoNormal">During one of the many Congressional hearings on stem cell research, Dr. Stuart Newman, a professor at New York Medical College, laid out the following scenario: in addition to human embryonic stem cells there is another class of pluripotent stem cells called human embryonic germ cells (n.b., Dr. Newman’s testimony [3/5/02] was given before the discovery of induced pluripotent stem cells [iPSCs]).<span> </span><span style="color: black;">“On purely scientific grounds,” Newman noted, “embryo germ cells show even greater promise than embryo <span>stem cells.”<span> </span>H</span></span>owever, while embryonic stem cells are typically harvested no later than seven days after conception, embryonic germ cells are derived from eight to nine week embryos.<span> </span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal">Deriving cells from such later term embryos would now be a “hot potato” Newman noted, but not for any scientific reason: “<span style="color: black;">I emphasize that all of this makes perfectly good scientific and medical sense. The only thing that stands in the way is the sense of propriety concerning the uses to which developing human embryos and fetuses may be put. Some of you may draw the line at the tiny clump of cells, others at the two-month embryo, still others somewhat short of full term. Wherever each of you decides to leave this particular train, there will be others who will insert their right to take it to the next station” (please note, Dr. Newman favors abortion rights and noted at the outset of his testimony that his views “do not derive from any notion of the sanctity of the embryo”).<o:p></o:p></span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal">“<i>All of this makes perfectly good scientific and medical sense</i>.” In the context of hESCR, letting science lead the way leads to the commodification of human life.<span> </span>It turns human life – and the human embryo is human life – into a commodity to be exploited as a means to what someone else deems a worthy end.<span> </span>And worthy has now come to include something as mundane as desiring smoother skin, as some cosmetic companies now boast the use of <a href="http://www.healthzone.ca/health/yourhealth/agingwell/article/721624--fetal-cells-in-skin-cream-a-bit-weird">fetal cells in their preparations</a>).<span> </span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal">If we used the same standard proponents used to justify hESCR – let “science” have the final say – there would be no reason to judge as “creepy” the experiments described in <i>Wired. </i><span> </span>But they are, as is destroying and exploiting human life as a means to someone else’s potential benefit.<span> </span><span> </span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal">Add hESCR as the eighth experiment on <i>Wired</i>’s list.</div>DNHhttp://www.blogger.com/profile/09946127168836977549noreply@blogger.comtag:blogger.com,1999:blog-1386591855300347068.post-1632878461844630862011-09-08T15:53:00.000-04:002011-09-08T15:53:33.396-04:00New Hope for Treating Kidney Disease<link href="file:///C:%5CUsers%5CGene%5CAppData%5CLocal%5CTemp%5Cmsohtml1%5C01%5Cclip_filelist.xml" rel="File-List"></link><o:smarttagtype name="country-region" namespaceuri="urn:schemas-microsoft-com:office:smarttags"></o:smarttagtype><o:smarttagtype name="State" namespaceuri="urn:schemas-microsoft-com:office:smarttags"></o:smarttagtype><o:smarttagtype name="City" namespaceuri="urn:schemas-microsoft-com:office:smarttags"></o:smarttagtype><o:smarttagtype name="place" namespaceuri="urn:schemas-microsoft-com:office:smarttags"></o:smarttagtype><o:smarttagtype name="PlaceName" namespaceuri="urn:schemas-microsoft-com:office:smarttags"></o:smarttagtype><o:smarttagtype name="PlaceType" namespaceuri="urn:schemas-microsoft-com:office:smarttags"></o:smarttagtype><style>
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<div class="MsoNormal">Two recent studies have been published which once again highlight the vast potential of induced pluripotent stems cells (iPSCs) to benefit patients, this time patients with kidney disease. Both studies were published in the <a href="http://jasn.asnjournals.org/content/22/7/1213.abstract">Journal of the American Society of Nephrology</a></div><div class="MsoNormal"><br />
</div><div class="MsoNormal"><a href="http://jasn.asnjournals.org/content/22/7/1213.abstract">In the first</a>, scientists at <st1:country-region w:st="on">Australia</st1:country-region>’s <st1:place w:st="on"><st1:placename w:st="on">Monash</st1:placename> <st1:placetype w:st="on">University</st1:placetype></st1:place>, led by Dr. Sharon Ricardo, extracted human kidney cells and reprogrammed them into iPS cells, which could then be transformed into other kidney cells that could potentially be transplanted to repair the damaged organ. </div><div class="MsoNormal"><br />
</div><div class="MsoNormal">In the <a href="http://jasn.asnjournals.org/content/22/7/1221.abstract">second report</a>, researchers at the <st1:placename w:st="on">Chinese</st1:placename> <st1:placetype w:st="on">Academy</st1:placetype> of Sciences in <st1:place w:st="on"><st1:city w:st="on">Guangzhou</st1:city></st1:place>, led by Dr. Miguel Esteban, found they could gather kidney cells from a patient’s urine and reprogram them into iPS cells. The reprogrammed cells, also, could be transformed into other kidney cells for potential transplant. An additional benefit is that scientists could freeze the urine cells for future use when needed.</div><div class="MsoNormal"><br />
</div><div class="MsoNormal">Other researchers into kidney diseases <a href="http://www.sharp.com/news/health/newsArticle.cfm?articleID=29658">hailed the reports</a>. Dr. Ivonne Schulman, an assistant professor of clinical medicine and nephrologist at the <st1:placetype w:st="on">University</st1:placetype> of <st1:placename w:st="on">Miami</st1:placename>'s Interdisciplinary Stem Cell Institute in <st1:state w:st="on"><st1:place w:st="on">Florida</st1:place></st1:state>, said that "Two papers back-to-back show that two different kidney cell types are able to be reprogrammed…This is very significant." She added: "It could theoretically help all types of kidney disease…it just depends on the ability of these cells to differentiate back into the cell types needed for that disease."</div><div class="MsoNormal"><br />
</div><div class="MsoNormal">Dr. Jeffrey I. Silberzweig, co-medical director of the Rogosin Institute Manhattan Dialysis Center in New York City, also welcomed the reports: "The idea that you can have the ability to do stem cell transplants during the early stage of kidney disease and regenerate the damaged part of the kidney would be a tremendous benefit for patients and the country as a whole."</div><div class="MsoNormal"><br />
</div><div class="MsoNormal">In addition to their potential use in transplants, the reprogrammed kidney cells could also be beneficial for disease modeling, to study the origins and development of kidney disease and for drug screening of new medications to treat kidney disease.</div><div class="MsoNormal"><br />
</div><div class="MsoNormal">Both these studies come soon after a report that scientists working with insulin producing beta cells successfully reprogrammed such cells to become iPSCs, and that these reprogrammed cells were very efficient in producing more beta cells for potential transplant. The researchers believe the reason for such efficiency is because the reprogrammed cells retain a “memory” of their origin as beta cells so they already have an “understanding,” as it were, of their purpose to generate additional beta cells. It may well be that scientists working with the reprogrammed kidney cells will find the same phenomenon at work here as well (see previous blog “Advances in Diabetes Research –Without hESCs”). </div><div class="MsoNormal"><br />
</div><div class="MsoNormal">Meanwhile, research using human embryonic stem cells (hESCs) to treat kidney disease shows that it has the potential to generate, well, a lot of talk about the potential of hESCs to treat kidney disease…</div>DNHhttp://www.blogger.com/profile/09946127168836977549noreply@blogger.comtag:blogger.com,1999:blog-1386591855300347068.post-14428425836652290242011-07-27T15:34:00.000-04:002011-07-27T15:34:01.995-04:00Advances in Diabetes Research -- without hESCsProminent foundations for diabetes research, led by the Juvenile Diabetes Research Foundation, have long been <a href="http://www.jdrf.org/index.cfm?page_id=102406">leading advocates</a> for human embryonic stem cell research (hESCR), giving scant attention to the promise of adult stem cells and other alternatives to embryonic stem cells to treat this disease.<br />
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How ironic, then, that two of the most promising advances in treating diabetes have nothing at all to do with embryonic stem cells. <br />
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First, a little background. With regard to diabetes, it has long been medical orthodoxy that once the body’s insulin producing beta cells, found in the pancreas, are destroyed they are gone forever – they do not regenerate. Thus, the promise of stem cells to treat diabetes was that they could be coaxed into becoming insulin producing cells suitable for transplantation for those suffering with diabetes. Proponents of hESCR claimed that embryonic stem cells would prove ideal for this task.<br />
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It seems things are turning out differently from what they so confidently predicted. <br />
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Scientists have actually had very <a href="http://www.stemcellresearch.org/facts/factsheet-04-03-02.htm">disappointing results</a> in their efforts to transform hESCs into pure colonies of beta cells suitable for transplant.<br />
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However, in a recent issue of <i><a href="http://www.sciencedirect.com/science/article/pii/S1934590911002931">Cell Stem Cell</a></i>, scientists report that induced pluripotent stem cells (iPSCs) derived from beta cells are very efficient at generating insulin producing cells that could be used for transplant.<br />
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The scientists involved in the study believe that because the iPSCs are derived from beta cells, they retain a “memory of what they once were,” thus making them actually more efficient than embryonic stem cells for generating insulin producing cells.<br />
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Lead researcher Professor Shimon Efrat of the Tel Aviv University <a href="http://www.diabeticlive.com/diabetes-101/diabetes-news/diabetes-cure-adult-stem-cells-or-embryonic-stem-cells/">stated</a>, “This discovery promises to advance the development of cell replacement therapy for diabetics, possibly leading to an effective alternative to organ transplants.” He added, “When generated from human beta cells, pluripotent stem cells, these memory cells act as though they are receiving a prompt from their past life; the cells already have some understanding of their purpose, making them more efficient in generating beta cells.”<br />
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As promising as this development is, others involved in research on diabetes point out that as long as the body continues its auto-immune attack on the pancreas, where the insulin producing beta cells are found, transplanting new beta cells will not provide a permanent cure – the body will just attack these newly transplanted cells as well. So these researchers have turned their attention on finding ways to stop the auto-immune reaction against the beta cells.<br />
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In June, before a meeting of the American Diabetes Association in San Diego, Dr. Denise Faustman presented <a href="http://www.latimes.com/health/la-he-bcg-diabetes-20110625,0,6341862.story">very positive findings</a> in her research to stop the underlying auto-immune attack responsible for diabetes. <br />
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In her research with mice (which Do No Harm has closely followed and reported on over the years) Dr. Faustman found that BCG, a relatively inexpensive vaccine typically used to treat tuberculosis, also stops the auto-immune attack that destroys the insulin producing cells in the pancreas. At first, she thought this was just the first step in treatment, the second being to transplant donated islet cells now that the threat of attack had been ended.<br />
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But to her amazement, it seemed that the pancreas began to regenerate islet cells on its own, without the need for any newly-transplanted cells. This directly contradicted the prevailing orthodoxy that once an insulin producing cell is gone, it is gone (scientific consensus, anyone?). When she first published her results in 2001, they were so controversial that she was not allowed to use the term “regenerate” because the scientific community “knew” an organ could not regenerate itself.<br />
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In a <a href="http://www.sciencemag.org/content/302/5648/1223.abstract">2003 paper</a> published in <i>Science</i>, Faustman confirmed her finding and speculated the adult stem cells found in the spleen were responsible for aiding the pancreas to regenerate the islet cells. <br />
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This was met with even greater skepticism. Nonetheless, by 2007 her findings had been replicated in six other labs, both here and overseas.<br />
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At the June meeting in San Diego of the ADA, Faustman reported positive findings for the first use of her protocol in humans. Six patients who were diagnosed with diabetes for an average of 15 years were divided into one group that received low-level doses of the BCG vaccine and one group that received a placebo. All those receiving the vaccine showed reduced levels of the cell responsible for attacking the pancreas, as well as indications that new production of insulin had begun. <br />
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Faustman now hopes to expand her trial with a larger number of patients and to win FDA approval to increase the amount of BCG used to treat them. <br />
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So within a month of each other, we hear of two very promising findings in the treatment of diabetes. One showed that iPSCs should prove very useful in producing insulin producing cells for transplant should they be needed. And the other showed that transplants may not be needed at all if the auto-immune attack on the pancreas can be stopped, allowing the cells to regenerate on their own.<br />
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And the thundering silence you hear are the reports about all the advances using hESCs to treat diabetes.DNHhttp://www.blogger.com/profile/09946127168836977549noreply@blogger.comtag:blogger.com,1999:blog-1386591855300347068.post-9261548810567230872011-07-27T15:24:00.001-04:002011-07-27T15:27:10.655-04:00The Spinning Never Stopsplease note: this blog was originally posted on 6/21/11 <br />
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The National Science Foundation (NSF) on June 10 issued a <a href="http://www.eurekalert.org/pub_releases/2011-06/nsf-sss061011.php">press release</a> calling attention to a study the NSF funded on stem cell research and published in the June 9 issue of the scientific journal <a href="http://www.cell.com/abstract/S0092-8674%2811%2900593-9">Cell</a>.<br />
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“Social scientists study impact of human adult stem cell research” the headline reads, followed by: “Researchers say human adult and embryonic stem cell research is complementary.”<br />
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The release then sums up the study’s main finding: “New research says studying both adult and embryonic stem cells can benefit medical science, but banning the study of either type could harm studies of the other.” The remainder of the release elaborates on this point to the effect that any effort to cut back or eliminate federal funding for human embryonic stem cell research (hESCR) would have negative effects for adult stem cell research as well.<br />
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Now Cell is a very specialized scientific journal with a subscription rate of <a href="http://www.cell.com/subscribe">$212 annually</a>, meaning most outside the scientific/research community will not have access to the full study described in the press release; for interested lay people, any information on the study will in all likelihood come from this press release.<br />
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But if you do read the original study in full, you will be struck by a rather amazing fact: what the press release reports actually has nothing to do with the study itself. <br />
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The study reports on the intersection of research using <i><a href="http://www.stemcellresearch.org/commentary/answeringcommonclaims.htm">induced pluripotent stem cells</a></i> iPSCs) and human embryonic stem cells (hESCs). It has nothing at all to do with adult stem cell research, adult stem cell research is never addressed or discussed and in fact the word “adult” only occurs twice in the whole study and on the last page at that (one is a reference to “two adult stem cell researchers” who brought a lawsuit challenging federal funding of hESCR and the other is at the very end of the study reflecting an opinion of the authors). <br />
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So outrageous was the deceptiveness of the press release vis-a-vis the actual study itself that David Prentice, PhD, a <a href="http://www.stemcellresearch.org/">Do No Harm founding member</a> and <a href="http://www.frc.org/get.cfm?i=by04h12">Senior Fellow for Life Sciences at the Family Research Council</a>, <a href="http://www.frc.org/newsroom/national-science-foundations-appalling-stem-cell-ignorance">said he was</a> “appalled that the National Science Foundation would publish an ideological paper that promotes embryo-destructive research by attempting to link such research to advances in iPS cell research. While even this possible linkage is questionable based on the limits of the data presented, NSF in its headlong rush to promote ES cell research goes over the edge in confusing and prejudicing the public.” <br />
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So where’s the confusion and why does it matter?<br />
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By equating iPSCs with adult stem cells, the press release deliberately confuses what are two separate and very distinct types of stem cells. As Dr. Prentice noted in his statement on the study and release: “While iPS cells provide an ethical method to form pluripotent stem cells almost identical to ES cells, from any person, but without embryo destruction,<i> iPS cells are not adult stem cells</i>” (emphasis added). <br />
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Why does this matter?<br />
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Because the release (which, as already noted, is where most interested lay people would find out about this study) would have you believe that the proven and ongoing success of adult stem cells to actually provide real therapeutic benefits to patients depends on continued federal funding for embryo destructive stem cell research. And this is simply not true, nor has it ever been true.<br />
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<a href="http://www.stemcellresearch.org/facts/treatments.htm">Adult stem cells have provided therapeutic benefits for human patients for 73 diseases and conditions</a>, including spinal cord injury; heart disease; multiple sclerosis; lupus; sickle cell anemia and Parkinson’s, among others. In contrast, only <a href="http://www.reuters.com/article/2011/05/10/stemcells-spine-idUSN1010116320110510">two patients</a> have been treated with hESCs, both in a clinical trial for spinal cord injury (no results have been reported yet) and <a href="http://www.reuters.com/article/2011/06/16/advancedcell-stemcells-idUSN1626088320110616">two more</a> are slated to receive injections of hESCs for two different types of vision loss. <br />
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The success that adult stem cell research has had in treating patients did not come from the use of hESCs and does not in any way depend on continued federal funding for embryo-destructive research. In fact, the case could be made that the exact opposite is true: continued federal funding for hESCR may actually be hurting adult stem cell research by drawing limited funds away from it -- the very research that is actually helping patients now. As evidence of this, consider that a <a href="http://www.advocatesinternational.org/sites/default/files/webfm/Sherley_v_Sebelius_June_25_2010.pdf">federal appeals court</a> agreed with two adult stem cell researchers that by funding ESC research, the Administration is depriving adult stem cell researchers of the opportunity they would otherwise have to access these funds and advance stem cell research that is ethically non-controversial and which everyone accepts. This “competitive disadvantage” is what gave the two adult stem cell researchers standing to sue the Department of Health and Human Services.<br />
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The NSF press release is just another misdirection, the latest in a long string of <a href="http://www.americanthinker.com/2010/08/playing_politics_with_stem_cel.html">deceptions and falsehoods </a>proponents of embryo-destructive research have used to advance their agenda.DNHhttp://www.blogger.com/profile/09946127168836977549noreply@blogger.com