California-based biotech company Geron Corp. announced today (Jan. 23) that it has received clearance from the U.S. Food and Drug Administration to begin trials for the world's first clinical study on human embryonic stem cell-based therapy.

Geron plans to initiate a Phase I multicenter clinical trial in up to 10 patients paralyzed due to spinal cord injury. Its treatment -- currently referred to as "GRNOPC1" -- uses embryonic stem cells coaxed to become nerve cells, which are injected into the spinal cord.

The FDA had been mulling over the decision ever since Geron filed its 21,000-page application for the trial in March. Last May, the FDA placed a hold on the petition to give them time to review the study. Approval came in a phone call on Wednesday afternoon, said Thomas Okarma, Geron's president and CEO, according to the Wall Street Journal.

"This marks the beginning of what is potentially a new chapter in medical therapeutics -- one that reaches beyond pills to a new level of healing," Okarma said in a statement.

"It's an exciting sign that the FDA is satisfied with the initial safety [reviews] of stem cell therapy," Stephen Dunn, director of research at Boca Raton, Fla., securities firm Dawson James, told The Scientist.

The decision comes hot on the heels of the inauguration of President Barack Obama, who is widely expected to lift former President George Bush's limits on stem-cell research funding.

But both the FDA and Geron said the timing of the announcement was coincidental. "The FDA looks to the science on these types of issues, and we approve [such applications] based on a showing of safety," Karen Riley, an FDA spokesperson, told the Wall Street Journal. "Political considerations have no role in this process."

Geron's stock soared today following the company's announcement.


Related stories:

Stem cell trial nearly a go?
[17th October 2008]

First embryonic stem cell trial stalled
[15th May 2008]

FDA mulls embryonic stem cell therapy
[11th April 2008]