The U.S. Food and Drug Administration (FDA) has approved StemCell 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 U.S. sites for its Phase I/II clinical trial for chronic spinal cord injury, which is currently underway in Switzerland and Canada
Roman Reed, President of the Roman Reed Foundation, said, “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.”