The company is planning to treat amyotrophic lateral sclerosis (ALS) patients through spinal injections of its stem cells via its patented human neural stem cell technology.
Neuralstem expects to conduct the trial at Emory University with Johnathan Glass, director of the Emory Neuromuscular Laboratory and director of the Emory ALS Center, as site principal investigator (PI). Eva Feldman, head of the A Alfred Taubman Medical Research Institute and De Jong professor of neurology at the University of Michigan Medical School, is expected to 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.
Richard Garr, president and CEO of Neuralstem, said: The filing of this investigational new drug (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.