StemCells Wins FDA Authorization of IND for Spinal Cord Injury
StemCells, Inc. (Nasdaq: STEM) announced today that the U.S. Food and Drug Administration (FDA) has authorized the Company'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.
"This IND is a significant step forward for our spinal cord injury program," said Stephen Huhn, MD, FACS, FAAP, 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 U.S. 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