Neuralstem Files FDA Application for ALS Adult Stem Cell Trial
MarketWatch, December 18, 2008
Neuralstem Inc. announced this morning that it has filed an IND (investigational new drug) application with the U.S. FDA (Food and Drug Administration) to begin the first ever human clinical trials for the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, with adult stem cells.
According to Richard Garr, J.D., president and CEO of Neuralstem, "Like all first human trials, this proposed trial is primarily designed to test the safety and feasibility of both our stem cells and our method of delivering the cells to the spinal cord in ALS patients. We are also proposing secondary endpoints which we hope will be able to measure a slowing down of the degenerative process."
The treatment will consist of spinal injections of the adult stem cells using the company's patented and proprietary technology. The clinical trials will take place at Emory University under the direction of Dr. Johnathan Glass, Director of the Emory Neuromuscular Laboratory and Director of the Emory ALS Center, pending offical FDA authorization.
Approximately 30,000 people in the U.S. alone are afflicted with ALS, which is a progressive neurodegenerative disease in which the deterioration of nerve cells and motor neurons progresses from a loss of muscular control to paralysis and ultimately death. Conventional medical modalities have thus far been unsuccessful in halting or reversing the course of the disease, which until now has been considered incurable. Adult stem cell therapies, however, constitute the first type of treatment that is actually capable of offering realistically achievable improvement.
According to Richard Garr, "The filing of this IND is an important event for Neuralstem, but it marks only the beginning of a process which includes working together with the FDA to approve the first human ALS stem cell trial, refining our understanding of how to optimize delivery of our cells into patients, and ultimately delivering a new treatment for patients with this currently incurable disease."
As described on their website, "Neuralstem, Inc. is a publicly traded biotherapeutics company whose mission is to apply stem cell research and its patented human neural stem cell technology to treat diseases of the central nervous system including ischemic paraplegia, traumatic spinal cord injury, ALS and Parkinson's disease. Our stem cell research has resulted in patent-protected technology that allows us to produce mature, commercial quantities of neural stem cells with the ability to control the differentiation of the cells into physiologically relevant human neurons and glia."