In its attempt to use stem cell technology to treat amyotrophic lateral sclerosis, Neuralstem, Inc. has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for a clinical trial. The company aims to use its patented Human Neural Stem Cell technology for the treatment.
Neuralstem expects to conduct the trial at Emory University with Dr. Johnathan Glass, M.D., Director of the Emory Neuromuscular Laboratory and Director of the Emory ALS Center, as site Principal Investigator (PI). Dr. Eva Feldman, M.D., Ph.D., Head of the A. Alfred Taubman Medical Research Institute and the De Jong Professor of Neurology at the University of Michigan Medical School, will be the overall PI for the ALS trial program. Formal approvals from these institutions to conduct the trial can come only after FDA approval of the trial protocol.
In pre-clinical work, the company’s cells have extended the life of rats with ALS (Lou Gehrig’s disease) as reported the journal TRANSPLANTATION, in collaboration with Johns Hopkins University researchers, and also reversed paralysis in rats with Ischemic Spastic Paraplegia, as reported in NEUROSCIENCE on June 29, 2007, in collaboration with researchers at University of California San Diego.
Neuralstem CEO and President, Richard Garr said,
“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.”
Source: Market Watch