12.02.13
The U.S. Food and Drug Administration (FDA) is allowing StemCells Inc. to expand its clinical trial enrollment for spinal cord treatment.
The agency has greenlighted StemCells' bid to expand a Phase I/II clinical trial to the United States and treat American spinal cord injury victims with purified neural stem cells. The Newark, Calif., company began the trial in Switzerland in September 2011 and received approval in June 2013 to expand the study toCanada.
StemCells is attempting to complete enrollment in the 12-patient trial by the first quarter of 2014. It has transplanted stem cells in seven patients so far, including at least one patient from the United States, at Balgrist University Hospital in Switzerland.
"This IND [investigational new drug] is a significant step forward for our spinal cord injury program. We now look forward to enrolling patients at U.S. and Canadian sites and easing the travel burden for North American-based patients," said Stephen Huhn, M.D., F.A.C.S., F.A.A.P., vice president, CNS Clinical Research at StemCells. "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. This is the company's fourth FDA-authorized IND, and the agency has now cleared clinical studies of our HuCNS-SC cells in all threeelements of the CNS [central nervous system] -- the brain, the eye and the spinal cord."
Earlier this year, StemCells reported that two of three patients with the worse kind of spinal cord injuries showed "considerable gains" in feeling sensations a year after receiving treatment.
"With this green light from the FDA, it will be much easier for American patients to participate in this innovative trial," Roman Reed, who was paralyzed during a college football game and now serves as president of the Roman Reed Foundation, said in a press release. "This is another step forward in our quest to find a cure for paralysis."
StemCells Inc. researches, develops and commercializes cell-based therapeutics and tools for use in stem cell-based research and drug discovery. The company's leading therapeutic product candidate, HuCNS-SC cells (purified human neural stem cells), currently is being tested as a potential treatment for various central nervous system disorders.
The agency has greenlighted StemCells' bid to expand a Phase I/II clinical trial to the United States and treat American spinal cord injury victims with purified neural stem cells. The Newark, Calif., company began the trial in Switzerland in September 2011 and received approval in June 2013 to expand the study toCanada.
StemCells is attempting to complete enrollment in the 12-patient trial by the first quarter of 2014. It has transplanted stem cells in seven patients so far, including at least one patient from the United States, at Balgrist University Hospital in Switzerland.
"This IND [investigational new drug] is a significant step forward for our spinal cord injury program. We now look forward to enrolling patients at U.S. and Canadian sites and easing the travel burden for North American-based patients," said Stephen Huhn, M.D., F.A.C.S., F.A.A.P., vice president, CNS Clinical Research at StemCells. "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. This is the company's fourth FDA-authorized IND, and the agency has now cleared clinical studies of our HuCNS-SC cells in all threeelements of the CNS [central nervous system] -- the brain, the eye and the spinal cord."
Earlier this year, StemCells reported that two of three patients with the worse kind of spinal cord injuries showed "considerable gains" in feeling sensations a year after receiving treatment.
"With this green light from the FDA, it will be much easier for American patients to participate in this innovative trial," Roman Reed, who was paralyzed during a college football game and now serves as president of the Roman Reed Foundation, said in a press release. "This is another step forward in our quest to find a cure for paralysis."
StemCells Inc. researches, develops and commercializes cell-based therapeutics and tools for use in stem cell-based research and drug discovery. The company's leading therapeutic product candidate, HuCNS-SC cells (purified human neural stem cells), currently is being tested as a potential treatment for various central nervous system disorders.