FDA Approves Continuation of ALS Stem Cell Trial | Woodruff Health …

Home Newsroom News Releases FDA Approves Continuation of ALS Stem Cell Trial

Oct.21, 2011

Jonathan Glass, MD Nicholas Boulis, MD

Emory University researchers have received approval from the Food and Drug Administration (FDA) to advance to the next phase of a landmark trial to treat patients with Amyotrophic Lateral Sclerosis (ALS) using human neural stem cells.

The Phase I trial, currently underway exclusively at Emory University, is designed to assess the safety of implanting neural stem cells into the spinal cord in up to 18 people with ALS and began in January 2010. The first 12 patients received neural stem cell transplants in the lumbar, or lower, region of the spinal cord. After reviewing safety data from these patients, the FDA has granted approval for the trial to advance to the final two groups of patients (three in each group), all of who will be transplanted in the cervical, or upper, region of the spinal cord.

This represents a major accomplishment for the trial, meaning that we have achieved our stated goal of proving safety in the first 12 patients who received lumbar spinal injections, says Jonathan Glass, MD, Professor of Neurology, Emory School of Medicine and director of the Emory ALS Center.

Our next objective is to demonstrate that we can deliver the cells safely to the cervical spinal cord, which is particularly important because therapy in this region may help patients better maintain their ability to breathe.

Nicholas Boulis, MD, Associate Professor of Neurosurgery at Emory School of Medicine, performs the surgery to implant the cells. He also developed the device used to inject the stem cells into the spinal cord, which received a notice of patent allowance from U.S. Patent and Trademark Office in October.

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