StemCells, Incorporated is conducting a Phase I/II clinical trial in which the company’s proprietary stem cell line, their HuCNS-SC stem cell lines, which is a purified human adult neural stem cell line, is implanted into the spinal cords of patients who have suffered a spinal cord injury. This clinical trial is designed to determine the safety and preliminary efficacy of HuCNS-SC as a treatment for spinal cord injury.
The goal for this clinical trial is to treat 12 patients who have suffered thoracic (chest-level) neurological injuries at the T2-T11 level. In order to be candidates for this procedure, the patients must have suffered their spinal cord injuries recent enough so that they can have the stem cells transplanted into their spinal cords within three to twelve months after their injury. The clinical trial will assess the safety of the procedure and its efficacy. Efficacy will be specifically assessed by determining the recovery of such features as sensation, motor function and bowel/bladder function. The first three patients have already been treated and these patients have spinal cord injuries that are classified as “ASIA category A.” This is a shorthand for American Spinal Injury Association category A. Category A means that there is no sensory or motor function below the level of the injury. The next group of patients to be treated will have less severe injuries (ASIA-B – sensory but no motor function below the level of the injury) and the third group will be even less severe injuries (ASIA-C – motor function is preserved, but most of the major muscle have reduced function).
The trial is being conducted at Balgrist University Hospital, University of Zurich, which is a world leading medical center for spinal cord injury and rehabilitation, and is open for enrollment to patients in Europe, Canada and the United States. Enrollment for those patients in the second cohort with ASIA-B category spinal cord injuries is now underway.
As previously reported, StemCells, Inc. reported at a conference on the results of their clinical trial. They reported that in six months after the first patients were treated, the patients showed no severe side effects. Even more favorably, the patients showed considerable gains in sensory function in two of the three patients compared to pre-transplant baselines. The third patient remains stable.
Armin Curt, M.D., the principal investigator for this clinical trial, presented these data at the 51st Annual Scientific Meeting of the International Spinal Cord Society in London, England. This clinical trial represents the first time that neural stem cells have been transplanted as a potential therapeutic agent for spinal cord injury. The recovery of sensory function in the two patients is certainly a remarkable finding, and gives new hope to those with a spinal cord injury.