The U.S. Food and Drug Administration has authorized the Investigational New Drug (IND) application for the clinical testing of StemCells, Inc.’s proprietary HuCNS-SC human neural stem cells for treating spinal cord injury. A Phase I/II clinical trial for chronic spinal cord injury is currently underway in Switzerland and Canada, and as a first action under the IND, StemCells, Inc. is endeavoring to open sites in the U.S.
Having obtained regulatory approval in Switzerland, Canada and now the U.S., StemCells, has the first international trial of a stem cell therapy for spinal cord injury. So far, seven patients from Germany, Norway, Italy, Israel, Canada, and the U.S. have received transplants at Balgrist University Hospital in Zurich, Switzerland. The company’s aim is to complete enrollment in the trial by the first quarter of 2014.
This is StemCells’ fourth FDA-authorized IND, and clinical studies have now been cleared for the company’s HuCNS-SC cells in all three elements of the CNS: the brain, eye, and spinal cord.
StemCells has not seen any safety issues thus far in the ongoing trial, and the company has reported very positive preliminary results, with sensory function gains persisting for 12 months after transplantation.
“This is great news for the spinal cord community,” said Roman Reed, president of the Roman Reed Foundation, a charitable organization engaged in the cause of finding cures for neurological disorders, particularly the alleviation of spinal cord injury paralysis. He added, “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.”
For more information about StemCells, Inc., visit www.stemcellsinc.com
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