STEM has received authorization to initiate a Phase I/II clinical trial of the HuCNS-SC(NYSE:R) product candidate (purified human neural stem cells) in chronic spinal cord injury from Swissmedic, the Swiss regulatory agency for therapeutic products.
The trial in Switzerland is designed to assess both safety and preliminary efficacy in patients with varying degrees of paralysis who are 3 to 12 months post-injury and will progressively enroll patients based upon the severity of injury.
- Enrollment is expected to begin in early 2011;
- The trial will enroll 12 patients with thoracic (chest-level) spinal cord injury, and will include both complete and incomplete injuries as classified by the American Spinal Injury Association (NASDAQ:ASIA) Impairment Scale;
- The first cohort will include patients classified as ASIA A. These patients have what is considered to be a “complete” injury, or no movement or feeling below the level of the injury;
- The second cohort will progress to patients classified as ASIA B, or patients with some degree of feeling below the injury;
- The third cohort will consist of patients classified as ASIA C, or patients with some degree of movement below the injury;
- In addition to assessing safety, the trial will evaluate preliminary efficacy using defined clinical endpoints, such as changes in sensation, motor, and bowel/bladder function.
The trial will be conducted in Zurich, Switzerland at the University Hospital Balgrist, University of Zurich, one of the leading medical centers in the world for spinal cord injury and rehabilitation. The principal investigator is Armin Curt, MD, Professor and Chairman, Spinal Cord Injury Center at the University of Zurich, and Medical Director of the Paraplegic Center at the University Hospital Balgrist. Dr. Curt is an internationally renowned medical expert in spinal cord injury
- Enrollment will be open to patients in Europe with thoracic spinal cord injury classified as ASIA A, B or C, and with a neurological injury level of T2-T11;
- All patients will receive HuCNS-SC cells through direct transplantation into the spinal cord, and will be temporarily immunosuppressed;
- Following transplantation, the patients will be evaluated regularly over a 12-month period in order to monitor and evaluate the safety and tolerability of the HuCNS-SC cells, the surgery and the immunosuppression, and to measure any recovery of neurological function below the injury site;
- STEM intends to follow the effects of this therapy long-term; a separate 4 year observational study will be initiated at the conclusion of this trial.