The U.S. company Neuralstem announced today that it has won approval from the FDA to begin clinical trials for the testing of its adult stem cell therapy as a treatment for ALS (amyotrophic lateral sclerosis), also known as Lou Gehrig’s disease.
According to Neuralstem, Phase I of the clinical trial will involve injection of its proprietary adult stem cell product directly into the grey matter of the lumbar area of the spinal cord of human patients who are suffering with varying degrees of the disease. The target enrollment is twelve patients who will be given between 5 and 10 injections of Neuralstem’s patented adult stem cell product. Data from the trial are expected in approximately 2 years.
Dr. Eva Feldman, director of the University of Michigan Health System ALS Clinic and the Program for Neurology Research and Discovery, will lead the trial. According to Dr. Feldman, "In work with animals, these spinal cord stem cells both protected at-risk motor neurons and made connections to the neurons controlling muscles. We don’t want to raise expectations unduly, but we believe these stem cells could produce similar results in patients with ALS."
It has been estimated that approximately 30,000 people suffer from ALS in the United States alone, with approximately 7,000 new cases diagnosed each year. Currently conventional medicine offers no known cure for ALS, which is a fatal disease characterized by progressive paralysis. With the advent of regenerative medicine, however, adult stem cells may prove to be the first actual therapy which not only reverses the course of the disease but which also regenerates damaged neurological tissue.
Although Neuralstem holds a number of patents for embryonic stem cell methods and processes in animal models, the company’s human stem cell product does not involve embryonic stem cells but instead is based exclusively upon adult stem cells that are derived from human adult CNS tissue.
Following today’s announcement of the FDA’s approval of the trial, Neuralstem’s stock increased 57%, or 21 cents, closing today at $2.08.
With corporate headquarters in Rockville, Maryland, Neuralstem was founded in 1996 by the current president and CEO, Richard Garr, J.D., and Merrill Solomon. As stated on their website, Neuralstem describes itself as "a biotherapeutics company utilizing its patented Human Neural Stem Cell technology", which "allows for the isolation of CNS (central nervous system) stem cells from tissue; the expansion in vitro of each cell up to a billion billion times (60 doublings), and the controlled differentiation of the cells into mature, physiologically relevant human neurons and glia."
(Please see the related news article on this website, entitled "Neuralstem Awarded Adult Stem Cell Patent", dated September 9, 2009).