The FDA has given Neuralstem (NASDAQ: CUR ) clearance to test its human spinal stem cell transplantation therapy, NSI-566, in patients with spinal cord injuries. The phase 1 trial will test the cell therapy on up to eight patients between one and two years after an injury that caused complete paralysis below their spinal cord damage. The first four patients will receive a lower dose, and the next four will receive a larger dose.
The primary purpose of the trial is to evaluate the safety of NSI-566, but Neuralstem will also evaluate how well the graft survives and whether it's able to increase functions, including motor and sensory function and bowel and bladder function.
Studies in paralyzed rats demonstrated that NSI-566 turned into neurons that extended across the break in the spinal cord, resulting in recovery of significant locomotor function.
NSI-566 has already been tested in a phase 1 trial in patients with amyotrophic lateral sclerosis, also known as ALS or Lou Gehrig's disease. Another clinical trial in ALS is expected to start this quarter.