Tag Archives: oligodendrocyte

Geron gets FDA OK for embryonic stem-cell based therapy

From BizJournals.com

The U.S. Food and Drug Administration has granted clearance of an investigational new drug application that lets Geron Corp. move forward with the world’s first study of a human embryonic stem cell based therapy in man, the company said late Thursday.

Menlo Park-based Geron (NASDAQ:GERN) said it plans to initiate a Phase I multi-center trial that is designed to establish the safety of the drug GRNOPC1 in patients with “complete” American Spinal Injury Association grade A subacute thoracic spinal cord injuries.

“The FDA’s clearance of our GRNOPC1 IND is one of Geron’s most significant accomplishments to date,” said Dr. Thomas B. Okarma, Geron’s president and CEO. “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 for the use of GRNOPC1 is restore spinal cord function by injecting hESC-derived oligodendrocyte progenitor cells directly into the patient’s injured spinal cord.”

Geron funded the original research at the University of Wisconsin-Madison that led to the first isolation of hESCs. The production of oligodendrocytes from hESCs is covered by patent rights licensed to Geron from the University of California.