Spinal cord injury often leads to paralysis. It is estimated that nearly 6 million Americans suffer some form of paralysis, of which 1.275 million people have sustained spinal cord injuries.
While there is currently no cure for the paralysis associated with spinal cord injuries, the FDA's decision to allow 'The Miami Project to Cure Paralysis' to begin trials in humans offers new hope.
On July 31, the Miami Project to Cure Paralysis, a Center of Excellence at the University of Miami Miller School of Medicine, received permission from the FDA to begin a revolutionary phase I clinical trial to evaluate the safety of transplanting human Schwann cells to treat patients with recent spinal cord injuries.
The clinical trial, which will be the only FDA-approved cell therapy-based clinical trial for sub-acute spinal cord injury in the United States, will enroll eight participants with an acute thoracic spinal cord injury. Schwann cells will be obtained from the patients and grown in a culturing facility for three to five weeks to generate the required number of cells for transplantation. Each participant will have his/her own Schwann cells transplanted at the injury site.
The participants will undergo intensive follow-up for one year after receiving the transplantation surgery, and their neurologic status, medical status, pain symptoms, and muscle spasticity will be evaluated. It could be at least two to three years from the time the first subject is enrolled until the final subject is one year post-transplantation, according to the researchers.
Complete injuries at or below the thoracic spinal levels result in paraplegia, a paralysis of the lower half of the body including both legs. Many of the paraplegics are dependent on wheelchairs or other supportive measures.
Miami Project researchers believe that Schwann cells, found in the peripheral nervous system and essential for sending appropriate electrical signals through the nervous system, are key to finding cures for paralysis.
While commenting on the latest development, Barth Green, Co-Founder and Chairman of The Miami Project drew parallels between the FDA's permission to begin trials in humans with Schwann cells to treat spinal cord injuries and man's first step on the moon.
Pascal Goldschmidt, Senior Vice President for Medical Affairs and Dean of the Miller School of Medicine, and CEO of UHealth-University of Miami Health System said, "This is truly one small Schwann cell for a human, and one giant leap for humankind and the search for cures for paralysis."
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