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FDA Approves Spinal Cord Injury Cell Replacement Trial

Posted on Aug 25, 2012

In a July 31, 2012, report, ABC News heralded the Food and Drug Administration (FDA)’s approval of an early-stage clinical trial of a certain type of spinal cord therapy. The trial will assess the safety of transplanting human Schwann cells as a treatment for patients with paralysis. This is the first study of its kind anywhere in the world.

Researchers hope to find that the cells, which send electrical signals from the peripheral nervous system to other parts of the body, will be the key to a cure someday for paralysis caused by spinal cord injuries. 

In the trial, researchers will inject eight patients with acute spinal cord injuries with Schwann cells taken from the patients’ own bodies. Scientists at the University of Miami Medical Center will watch the patients closely to determine whether there are any adverse effects. 

This is the only trial of its kind being conducted in the United States at this time.

On hand for the FDA’s announcement were Nick Buoniconti, who is a Pro Football Hall of Fame linebacker, and his son, Marc Buoniconti, who was injured in a college football game at The Citadel in South Carolina and has been paralyzed from the neck down for the last 27 years. 

Both father and son have been activists in the movement to find a cure for paralysis. After his son’s injury, Nick Buoniconti, working together with his son’s neurosurgeon, founded The Miami Project. This group works exclusively to find a cure for spinal cord injuries. 

On the day of the announcement, Nick Buoniconti said, “My family made a promise to Marc and all those living with paralysis that nothing will stand in the way of us finding a cure, absolutely nothing. FDA approval of this clinical trial is allowing us to follow through on this incredibly important commitment that impacts millions of families each day.”

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John L. Keefe
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