Human embryonic stem cell trial delayed

The only clinical trial approved by the FDA using cells created from embryonic stem cells has now been put on hold by the FDA. The delay occurred before any patients were enrolled in the study. No patients have yet to be successfully treated with embryonic stem cells.

The halt was ordered after Geron shared data from dose escalation studies in animals with the Food and Drug Administration, the company said. The therapy is meant to restore movement to paralyzed people by injecting nerve cells made from embryonic stem cells to the site of the injury.

In January, the F.D.A. lifted a delay on the clinical trial from May 2008. The action on Tuesday was probably based on safety concerns that emerged from the new higher-dose data the company had submitted, said Joseph Pantginis, an analyst with the Merriman Curhan Ford Group in New York.

FULL STORY