The US Food and Drug Administration (FDA) has authorized the StemCells, Inc's Investigational New Drug (IND) application for clinical testing of the company's proprietary HuCNS-SC human neural stem cells as a treatment for spinal cord injury. As a first action under this IND, the company is working to open US sites for its phase I/II clinical trial for chronic spinal cord injury, which is currently underway in Switzerland and Canada.

"This IND is a significant step forward for our spinal cord injury programme," said Stephen Huhn, vice president, CNS Clinical Research at StemCells, Inc.  "With regulatory authorization from Switzerland, Canada and now the United States, we have the first international trial of a stem cell therapy for spinal cord injury.  To date, we have transplanted seven patients from Germany, Norway, Italy, Israel, Canada, and the United States at Balgrist University Hospital in Zurich. We now look forward to enrolling patients at US and Canadian sites and easing the travel burden for North American-based patients. Our goal is to complete enrollment in the trial by the first quarter of next year. This is the Company's fourth FDA-authorized IND, and the agency has now cleared clinical studies of our HuCNS-SC cells in all three elements of the CNS, the brain, the eye and the spinal cord."

Roman Reed, president of the Roman Reed Foundation, added, "This is great news for the spinal cord community. StemCells has not seen any safety issues in the ongoing trial, and they have reported truly exciting preliminary results, with gains in sensory function persisting for 12 months after transplantation. With this green light from the FDA, it will be much easier for American patients to participate in this innovative trial. This is another step forward in our quest to find a cure for paralysis."

The Roman Reed Foundation is a charitable organization dedicated to the cause of finding cures for neurological disorders, in particular the alleviation of spinal cord injury paralysis.

The company's phase I/II clinical trial is designed to assess both safety and preliminary efficacy of HuCNS-SC cells as a treatment for chronic spinal cord injury. The company plans to enroll twelve patients with thoracic (chest-level) neurological injuries at the T2-T11 level, with the injury classified as complete or incomplete according to the American Spinal Injury Association Impairment Scale. To date, seven patients have been enrolled and transplanted with HuCNS-SC cells.

All patients who enroll will receive HuCNS-SC cells through direct transplantation into the spinal cord and will be temporarily immunosuppressed. Patients will be evaluated regularly in the post-transplant period in order to monitor and assess the safety of the HuCNS-SC cells, the surgery and the immunosuppression, as well as to measure any change in neurological function below the injury site. Preliminary efficacy will be evaluated based on defined clinical endpoints, such as changes in sensation, motor function and bowel/bladder function. The company intends to follow the effects of this therapy long-term, and each of the patients will be invited to enroll into a separate four-year observational study after completing the phase I/II study.

Data from the first three patients, each of whom had suffered a complete injury prior to enrolling in the study, showed multi-segment gains in sensory function in two patients twelve months after transplantation of the HuCNS-SC cells. One of the two converted from a complete injury classification to an incomplete injury. The third patient remained stable twelve months after transplantation.

StemCells, Inc. is engaged in the research, development, and commercialization of cell-based therapeutics and tools for use in stem cell-based research and drug discovery.