Friday, January 23, 2009

F.D.A. Approves A Stem Cell Trial

Photo: Geron’s trial with embryonic stem cells will involve people with severe spinal injuries, and will mostly test the therapy’s safety. Geron

From The New York Times:

In a research milestone, the federal government will allow the world’s first test in people of a therapy derived from human embryonic stem cells.

Federal drug regulators said that political considerations had no role in the decision. Nevertheless, the move coincided with the inauguration of President Obama, who has pledged to remove some of the financing restrictions placed on the field by President George W. Bush.

The clearance of the clinical trial — of a treatment for spinal cord injury — is to be announced Friday by Geron, the biotechnology company that first applied to the Food and Drug Administration to conduct the trial last March. The F.D.A. had first said no, asking for more data.

Thomas B. Okarma, Geron’s chief executive, said Thursday that he did not think that the Bush administration’s objections to embryonic stem cell research played a role in the F.D.A.’s delaying approval.

“We really have no evidence,” Dr. Okarma said, “that there was any political overhang.”

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