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<DIV class="float-left position-relative margin-top-minus-22"><SPAN
class=small>From </SPAN><SPAN class=byline>The Times</SPAN></DIV>
<DIV class="small color-666">January 24, 2009<BR></DIV>
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<H1 class=heading>Blindness is the next target for stem-cell therapy after US
opens way to new trials</H1>
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<DIV class=article-author><!-- Print Author name from By Line associated with the article --><SPAN
class=small></SPAN><SPAN class=byline>Mark Henderson, Science Editor </SPAN>
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<P>British scientists will apply this year to start patient trials of an
embryonic stem-cell therapy for the commonest cause of blindness.</P>
<P>If approved, the study will be the second of its kind, after US regulators
yesterday cleared the first human trial of the powerful master cells. The US
decision to approve the trial of a paralysis treatment by the Geron Corporation
will open the way for a team at University College London to test a similar
therapy for age-related macular degeneration (AMD) on patients.</P>
<P>Pete Coffey, of UCL, who is leading the project, said that the approval of
the paralysis trial was “bloody good news”.</P>
<P>“It clearly gives a lot of direction to our regulators. It is a precedent of
sorts. Our therapy is now very advanced. We are now into the final stages of
preclinical work-up. We’re already in discussions with the regulatory
authorities in the UK, and the fact that Geron’s trial is going forward makes
the process, I hope, more achievable. We will be making an application later
this year, and I would hope we’ll go into patient trials some time in 2010 or
2011.”</P>
<P>Embryonic stem cells are master cells found in human embryos that give rise
to all the specialised tissues in the body. They have exciting medical potential
as a source of replacement tissue for treating disease or injury, though their
use is controversial because they involve the destruction of human embryos.</P>
<P>The Geron trial, which will begin in the summer, will be the first to test on
patients a therapy based on embryonic stem cells. It will investigate the safety
and effectiveness of injecting specialised spinal cells grown from the master
tissue into people paralysed from the chest down.</P>
<P>Robert Klein, the chairman of the California Institute for Regenerative
Medicine, said that the treatment for AMD, which affects up to one in four
people aged over 65, was likely to be the second therapy based on embryonic
tissue to enter clinical trials.</P>
<P>Professor Coffey has already used embryonic stem cells to grow a type of eye
tissue known as retinal pigment epithelium cells, which are destroyed in AMD,
leading ultimately to blindness. These have proved effective at reversing the
eye damage caused by AMD in animal models, and the team is now finalising the
safety data it needs before it can start patient trials. Approval must be
granted by three bodies: the Human Tissue Authority, the Medicines and
Healthcare products Regulatory Agency and the Gene Therapy Advisory
Committee.</P>
<P>The therapy will be tested initially on patients with the dry form of AMD,
which affects 90 per cent of sufferers and is incurable. It is expected
ultimately to be suitable for the less common wet form as well.</P>
<P>Many scientists have warned against placing too much hope in the technology.
Geoff Raisman, of UCL, who is researching an adult stem-cell therapy for spinal
cord injuries, said that he was unsure whether Geron’s approach would work. “It
isn’t clear that the mechanism they are targeting is the main cause of paralysis
after spinal injury,” he said. “There is nothing wrong with doing trials, but it
is important not to build up expectations too much.”</P>
<P>Stephen Minger, of King’s College London, said: “I have concerns about
paralysis as the first application. It is not a life-threatening condition:
these are young people who have fallen off motorbikes, and they’re going to live
a long time. If there are any serious side-effects, there could be a negative
impact on the field.”</P>
<P>Peter Wilderotter, president of the Christopher and Dana Reeve Foundation,
said that the late <I>Superman</I>actor, who was paralysed in a riding accident,
would have been excited by the research. “There has been so much speculative and
unsubstantiated information about the use of stem cells in spinal cord injury;
it is important to study these cells in a rigorously designed clinical trial.”
</P>
<P>Sean Tipton, a former president of the Coalition for the Advancement of
Medical Research, said that he expected President Obama would soon lift the
restrictions that George Bush had imposed on stem-cell
research.</P></DIV></DIV></FONT></DIV></BODY></HTML>