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MultiVu Video Feed: Geron Receives FDA Clearance to Begin World's First Human Clinical Trial of Embryonic Stem Cell-Based Therapy
Date:1/23/2009

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.

    For more information about GRNOPC1, please visit:http://www.geron.com

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