Stem Cell Trial Approved by FDA

Stem Cell Trial Wins Approval of F.D.A.

The world’s first authorized test in people of a therapy derived from human embryonic stem cells has been cleared by the Food and Drug Administration.

The clinical trial could offer the first glimpse of the safety and possible effectiveness of a technology that has been hailed for its vast medical promise but also embroiled in political and ethical controversy.

The trial will test cells developed by the Geron Corporation and the University of California, Irvine in patients with new spinal cord injuries.

The F.D.A. had initially cleared the clinical trial in January 2009. But before any patients could be treated, the agency suspended the trial after cysts were discovered in some rats injected with the cells. Geron had to do another rat study and develop better ways to check cell purity.

On Friday, the company announced that the F.D.A. had lifted the hold. Geron’s shares rose 17 percent, to $5.63.

Embryonic stem cells can turn into any type of cell in the body. Scientists envision one day making replacements for injured or diseased tissues to treat a wide variety of illnesses.

“I think it’s a very important milestone for the whole industry,” Alan Trounson, the president of California’s stem cell agency, said Friday, adding that the hold on the trial had been a cloud over the field. “It’s very important that they get on and treat the patients and demonstrate the safety” of the therapy.

READ MORE/New York Times