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FDA clears way for stem-cell therapy testing on humans

By Ed Yeates | Posted - Jan. 23, 2009 at 6:49 p.m.



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The Food and Drug Administration has approved the world's first human clinical trial of embryonic stem-cell therapy to treat spinal cord injuries.

There's been a lot of work already on this new investigational stem cell drug, but researchers want to see now how safe it is in humans and what it can really do to reverse damage from spinal cord injuries.

Researchers have been waiting a long time for is this landmark FDA move to allow the use of restricted embryonic stem cells -- pristine cells in that early 64-cell embryonic stage that go to any organ or tissue and rebuild on command.

"We engineer the cell in such a way that it thinks it's making a new body part," explained Dr. Thomas Okarma, with Geron Corporation.

When rats with spinal injuries were injected with their own species' embryonic stem cells, they regained movement in their hind legs. For folks like Joseph, Chris, Brandon, Derick and Preston, who all have permanent spinal cord injuries and are going through rehab at Utah's Neuroworx, human clinical trials are long overdue.

"It's exciting for everybody in the spinal cord community. I mean this is kind of the light at the end of the tunnel," Joseph Taggart said.

That light at the end of the tunnel could range anywhere from a little to a lot. The hope, from a point where there is no locomotion, no sensation at all, is that patients will be able to respond to physical therapy and actually get better over time.

"It's exciting to think someone can walk again or regain some kind of function back in their arms or something. I mean, it would be amazing," patient Brandon Gillen said.

Dr. Dale Hull, himself a victim of partial paralysis, says while we have to deal with the moral issues of using these cells, the alternative is worse.

"What I feel very strongly about is that it's unethical and immoral to ignore the opportunities that medicine and science are presenting to help people with these devastating injuries," Hull said.

For stem cell labs, the door now will open wide. "I think this will open a lot of new therapies that we will be able to participate in," said Dr. Kinda Kelley, director of the University of Utah Stem Cell Laboratory.

In fact, the University of Utah Stem Cell Lab is now getting a multimillion-dollar grant to research adult stem cell therapy to treat ALS, or Lou Gehrig's disease.

E-mail: eyeates@ksl.com

Ed Yeates

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