Friday, January 23, 2009

GERON RECEIVES FDA CLEARANCE TO BEGIN WORLD'S FIRST HUMAN CLINICAL TRIAL OF EMBRYONIC STEM CELL-BASED THERAPY

Source: Geron Corporation
Date: January 23, 2009

Summary:

In an official company news release, Geron Corporation, a biotechnology company in the field of stem cell research, announced it received federal regulatory approval to begin human clinical trials to treat patients with acute spinal cord injuries using human embryonic stem cells:

"Geron Corporation announced today 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 cell (hESC)-based therapy in man. Geron plans to initiate a Phase I multi-center trial that is designed to establish the safety of GRNOPC1 in patients with "complete" American Spinal Injury Association (ASIA) grade A subacute thoracic spinal cord injuries."