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Geron sees progress in stem-cell therapy
STUDY OF HEART ATTACK PATIENTS
By Steve Johnson
Mercury News
Article Launched: 08/27/2007 01:37:54 AM PDT


Geron, which hopes to soon begin human tests of its human embryonic
stem-cell-derived treatment for damaged spinal cords, on Sunday reported
progress with another potential stem-cell treatment for heart attack
victims.
In a study published in the journal Nature Biotechnology, the Menlo Park
company and researchers at the University of Washington said they had used
human embryonic stem cells for the first time to help regrow heart muscles
in rats that had suffered heart attacks.
The study is preliminary. But Geron's Chief Executive, Tom Okarma, said he
is highly encouraged by its findings. He added that Geron expects to gather
enough data on the technique to ask the U.S. Food and Drug Administration in
late 2008 or early 2009 for permission to test the concept on people.
Geron is even closer to seeking FDA approval for an unprecedented human test
of another treatment it is developing from human embryonic stem cells for
spinal injuries, Okarma said. Although Geron executives had hoped to begin
such a test last year, Okarma said the company now plans to ask the FDA in
the next couple of months for permission to start it.
Many studies are under way in people using treatments made from adult stem
cells, which are specialized cells that grow into certain types of tissues.
But the FDA has never approved human tests with human embryonic stem cells,
which can grow into any tissue in the body.
That's partly because the embryonic variety haven't been studied as long as
the adult kind. In addition, the Bush administration has severely limited
federal financing for human embryonic stem-cell studies, because those cells
come from discarded embryos.
Despite the Bush administration's stance, however, Okarma said he has gotten
no indication from FDA officials that they would reject his request to test
the cells in people.
"We have absolutely zero evidence that the White House policy that is so
restrictive on embryonic stem-cell research has had any influence on the
FDA," he said.


Contact Steve Johnson at [log in to unmask] or (408) 920-5043.

Rayilyn Brown
Board Member AZNPF
Arizona Chapter National Parkinson's Foundation
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