This story was corrected on Jan. 15, 2013. An explanation follows the story. Physicians, researchers, patients and their advocates in the spinal injury field are keeping a close eye on Rockville biotech Neuralstem as it prepares to launch a Phase 1 safety trial of its stem cell treatment for chronic spinal cord injury. The Food and Drug Administration approved the trial Monday. Neuralstem plans to conduct the study on eight patients who are completely paralyzed at or below their spinal cord injuries. Its important that people understand this is very different from other methods that have gone on before, CEO Richard Garr said. This is the real deal. We have compelling data. Cells are surviving, grafting and doing what we would expect they would do. The FDA go-ahead follows Neuralstems report in October that rats given the stem cell product, NSI-566, seven days after suffering an ischemic stroke showed improvement in motor and neurological tests. Should this prove to be successful, it will allow for some regeneration of human spinal cord cells and for people to regain function. It will be an incredible breakthrough, with huge implications for the health care market, said Paul Tobin, president and CEO of the … Continue reading
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