I found the article below from Drug Discovery & Development (www.dddmag.com) which talks about the current steps the FDA has taken to be a part of the international effort to find a cure for paralysis. I know research involving stem cells is controversial but, if it were to lead to a cure for paralysis, it sure would make a difference in the lives of so many.
FDA OKs Stem Cell Trial for Spinal Cord Injuries
The U.S. Food and Drug Administration (FDA) has authorized the StemCells Inc.’s Investigational New Drug (IND) application for clinical testing of the company’s 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 1/2 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 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.”
Date: October 2, 2013
Source: StemCells Inc.
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