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FDA Approves Safety Trial of Promising Experimental Paralysis Treatment

Spinal-cord injury is a diagnosis no one ever wants to hear. Almost three decades ago, Marc Buoniconti became a quadriplegic in a stunning instant in a college football accident. In 1985, together with his famous football-player father, Nick Buoniconti, and neurosurgeon Dr. Barth Green, Marc established The Miami Project to conduct spinal-cord-injury research at the University of Miami Medical Center in Florida.

And the decades of work and millions of dollars in donations may be paying off soon, as the federal government has approved that the project conduct a phase 1 clinical trial in eight people with new spinal-cord injuries to see whether a patient’s own Schwann cells can be safely transplanted to the site of a spinal-cord injury in the hopes of reversing the course of paralysis.

What Is a Spinal-Cord Injury?

Damage to the spinal cord – sometimes from a disease like cancer or arthritis, but often from severe trauma like a motor-vehicle accident, sporting mishap, fall or gunshot wound – can cause permanent impairment of the body below the place of the injury, including paralysis or other lesser limitations on movement, strength, muscle control, function and feeling. What ultimately happens to an individual sustaining a spinal cord injury depends on where the damage is and how bad it is.

Specific symptoms may include loss of muscle control, pain, incontinence, spasms, circulatory problems, sexual dysfunction, infertility, and trouble with coughing or breathing. Individuals who experience severe lifestyle restrictions from spinal-cord injury may, not surprisingly, also suffer from depression and grief.

How Might the Schwann-Cell Transplants Help?

Acting like stem cells, Schwann cells are found in periphery nerves sending out electrical signals. Doctors hope that injecting them into spinal-cord injury sites might bring long-term restoration of sensation and movement to paralyzed patients. According to an ABC News article, a similar experiment with paralyzed lab animals reversed 70 percent of their “function and movement.”

Doctors in the Schwann-cell transplant trial will monitor the eight patients carefully for side effects as this is the first such treatment on humans. Phase 1 clinical trials focus mainly on patient safety so if the procedure appears to be safely tolerated, further phases of trials may be considered.

Anyone whose spinal-cord injury may have been caused – even in part – by the negligence or malfeasance of another person should discuss the situation with an experienced personal injury attorney. The cost of needed medical care, rehabilitation, medical equipment and home modification can be astronomical, and a lawyer can assess whether the injured party has legal rights and remedies that could help cover these associated financial costs.

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