Geron says FDA will allow embryonic stem cell study; safety concerns caused 11-month delay

Geron says FDA lifts hold on stem cell trial

MENLO PARK, Calif. — Regulators are giving the all-clear to a clinical trial that will test embryonic stem cells as a treatment for spinal cord injury, says the developer of the treatment, Geron Corp.

Geron says the Food and Drug Administration removed a clinical hold on its GRNOPC1 therapy. The FDA accepted Geron’s study application in January 2009, but in August it placed the trial on hold because some mice treated with GRNOPC1 developed microscopic spinal cysts.

Geron plans to test GRNOPC1 at seven sites nationwide but did not say when it will start the trial. Early clinical trials focus on safety. It will test the therapy as a treatment for acute spinal cord injury, injecting it into the spine one to two weeks after the patients suffer an injury.