StemCells Inc. announced today that the U.S. Food and Drug Administration, or FDA, has authorized the firm’s Investigational New Drug, or IND, application for clinical testing of its proprietary HuCNS-SC(R) human neural stem cells as a treatment for spinal cord injury.
The company noted that as a first action under this IND, it 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. 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,” said Stephen Huhn, Vice President, CNS Clinical Research at StemCells Inc.
This is truly a fantastic move forward for chronic spinal cord injury. These ongoing human trials can be pivotal in getting a treatment or therapy to those already suffering paralysis.