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 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 National Spinal Cord Injury Association.

More than 10,000 people in the U.S. sustain spinal cord injuries each year, according to the Christopher & Dana Reeve Foundation. About 840,000 people have chronic spinal cord injury. Currently, the best treatment is mitigating secondary damage and providing environments and tools that support patients with these injuries, Tobin said.

While Tobin emphasized that the industry is still far from a cure yet, the Neuralstem treatment could be a tremendous step and appears to be worth exploring.

The primary objective of the study is to determine the safety and toxicity of human spinal stem cell transplants for treating paralysis and related symptoms due to chronic spinal cord injury, according to Neuralstem information. A secondary objective is evaluating graft survival in the transplant site.

All patients will receive six injections in or around the injury site, with the first four patients receiving 100,000 cells per injection and the second four receiving 200,000 cells per injection. The study will follow the patients for six months after the procedures.

Following Mondays announcement, stock analyst Aegis Capital of New York raised its 12-month price target for Neuralstem to $4 from $3.50.

Investors should note the fact that spinal cord injury is the clinical indication that most closely mirrors the situation in the preclinical rat model that yielded the ground-breaking data published in the [trade journal] Cell last year, Aegis wrote in a report Monday.

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