Aug. 27, 2012
/PRNewswire/ -- Neuralstem, Inc. (NYSE MKT: CUR) announced the completion of the Phase I trial of its NSI-566 spinal cord neural stem cells for the treatment of amyotrophic lateral sclerosis (ALS or
's disease), with the eighteenth patient treated. This patient, the third to return to the trial for an additional set of injections, is also the last in the Phase I portion of the trial as it is currently designed, which is scheduled to conclude six months after this final surgery.
"We are delighted to have completed Phase I in this groundbreaking trial, the first approved by the FDA to test neural stem cells in patients with ALS," said
, PhD, Chairman of Neuralstem's Board of Directors and Chief Scientific Officer.
"There have been many firsts in this trial, including the first lumbar intraspinal injections, the first cervical region intraspinal injections, and the first cohort of patients to receive both," said
Jonathan D. Glass
, MD, Director of the Emory ALS Center. "This has required incredible effort from the Emory medical and support team and I wish to express my thanks to all of them, as well as to acknowledge the generosity and courage of the patients and their families."
"We have found the procedure to be extremely safe," said
, MD, PhD, Director of the A. Alfred Taubman Medical Research Institute and Director of Research of the ALS Clinic at the
University of Michigan
Health System. "In some patients, it appears that the disease is no longer progressing, but it is too early to know if the result from that small number of patients is meaningful." Dr. Feldman is the principal investigator (PI) of the trial and an unpaid consultant to Neuralstem.
About the Trial
The Phase I trial to assess the safety of Neuralstem's NSI-566 spinal cord neural stem cells and intraspinal transplantation method in ALS patients has been underway since
. The trial was designed to enroll up to 18 patients, the last of which was just treated. The first 12 patients were each transplanted in the lumbar (lower back) region of the spine, beginning with non-ambulatory and advancing to ambulatory cohorts.
The trial then advanced to transplantation in the cervical (upper back) region of the spine. The first cohort of three was treated in the cervical region only. The last cohort of three received injections in both the cervical and lumbar regions of the spinal cord. In an amendment to the trial design, The Food and Drug Administration (FDA) approved the return of previously treated patients to this cohort. The entire 18-patient trial concludes six months after the final surgery.