ROCKVILLE, Md., Oct. 9, 2013 /PRNewswire/ -- Neuralstem, Inc. (NYSE MKT: CUR) announced that the University of Michigan Health System, in Ann Arbor, Michigan, treated its first two patients in the Phase II trial testing NSI-566 neural stem cells in amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). This completes the first cohort in Phase II, which is also being conducted at Emory University Hospital, in Atlanta, Georgia. Phase II is a dose escalation trial designed to treat up to 15 patients with a maximum of 40 injections and up to 400,000 cells per injection. All patients will be ambulatory and within approximately two years of the onset of disease symptoms. The trial is under the direction of Eva Feldman, MD, PhD, Director of the A. Alfred Taubman Medical Research Institute, Director of Research of the ALS Clinic at the University of Michigan Health System and the President of the American Neurological Association. Dr. Feldman is an unpaid consultant to Neuralstem.
About the Trial
Neuralstem's NSI-566/ALS Phase II dose escalation trial is designed to treat up to 15 ambulatory patients in five different dosing cohorts, under an accelerated dosing and treatment schedule. The first 12 patients, divided into four cohorts, will receive injections in the cervical region of the spinal cord only, where the stem cells could help preserve breathing function. The first cohort, just completed, received 10 cervical region injections of 200,000 cells per injection. The trial will now progress to a maximum of 20 cervical injections of up to 400,000 cells per injection in the cervical-only cohort. The last three Phase II patients will receive injections in both the cervical and the lumbar spinal regions. These patients will receive 20 injections of 400,000 cells each in the lumbar region, in addition to the 20 injections they will already have received in their cervical region.