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 chapter in medical therapeutics â€“ 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 to achieve restoration of spinal cord function by the injection of hESC-derived oligodendrocyte progenitor cells directly into the lesion site of the patient's injured spinal cord.
The neurosurgical community is very excited by this new approach to treating devastating spinal cord injury. Demyelination is central to the pathology of the injury, and its reversal by means of injecting oligodendrocyte progenitor cells would be revolutionary for the field. If safe and effective, the therapy would provide a viable treatment option for thousands of patients who suffer severe spinal cord injuries each year, commented Richard Fessler, M.D., Ph.D., professor of neurological surgery at the Feinberg School of Medicine at Northwestern University