Geron Corp. (GERN) Gains FDA Clearance to Begin World’s First Human Clinical Trial of Embryonic Stem Cell-Based Therapy
History was made today as Geron Corp. 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. This unprecedented clearance enables the company to move forward with the world’s first study of a human embryonic stem cell (hESC)-based therapy in man. “The FDA’s clearance of our GRNOPC1 IND is one of Geron’s most significant accomplishments to date,” stated Thomas B. Okarma, Ph.D., M.D., Geron’s president and CEO. “This marks the beginning of what is potentially a new…