First ever study of human stem cell treatment

The FDA says yes to the world's first study in man of a human embryonic stem cell based therapy to treat spinal injury.

By Loth Hammar

January 28, 2009 12:00 AM

The U.S. Food and Drug Administration

have approved an Investigational New Drug application from Geron Corporation. The company can now move forward with a ground-breaking clinical trial of a candidate called GRNOPC1 in patients with acute spinal cord injury. This will be world’s first study of a human stem cell treatment on human patients.

Geron plans to initiate

a Phase I multi-center trial, designed to establish the safety of GRNOPC1 in patients with subacute thoracic spinal cord injuries. The study will be conducted in up to seven U.S. medical centers.

"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: the restoration of organ and tissue function achieved by the injection of healthy replacement cells. The ultimate goal is to achieve restoration of spinal cord function by the injection of hESC-derived oligodendrocyte progenitor cells directly into the lesion site of the patient's injured spinal cord." says Thomas B. Okarma, Geron's president and CEO, in a press statement

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