Geron to Study GRNOPC1 in Patients with Acute Spinal Cord Injury
Geron Corporation (Nasdaq: GERN) announced that the U.S. Food and Drug Administration (FDA) has granted clearance of the company's Investigational New Drug (IND) application for the clinical trial of GRNOPC1 in patients with acute spinal cord injury. The clearance enables Geron to move forward with the world's first study of a human embryonic stem (hESC) cell-based therapy in man.
Geron plans to initiate a Phase I multicenter trial that is designed to establish the safety of GRNOPC1 in patients with "complete" American Spinal Cord Injury Association (ASIA) Grade A subacute thoracic spinal cord injuries. Patients eligible for the Phase I trial must have documented evidence of functionally complete spinal cord injury with a neurological level of T3 to T10 spinal segments and agree to have GRNOPC1 injected into the lesion sites between seven and 14 days after injury.
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NEWS: World's First Study of Human Embryonic Stem Cell-Based Therapy In Man
FORMAT: B-roll and Soundbites
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SOUNDBITES: * Thomas B. Okarma, Ph.D., M.D., President, CEO and Director, Geron Corporation B-ROLL INCLUDES: * spinal cord cell therapy animation * lab and manufacturing footage * Geron office building exterior shots
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|SOURCE Geron Corporation|
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