Allan Levi, M.D. Performs World’s First Nerve Graft

Nerve Graft Surgery Performed Using a Patient’s Own Cells to Try to Repair a Severe Peripheral Nerve Injury

October 2013 – Dr. Allan Levi, director of clinical research at The Miami Project to Cure Paralysis recently performed the world’s first nerve graft using a combination of a patient’s own nerve and her own Schwann cells in an attempt to repair a severely injured sciatic nerve. The FDA approved study took place at the University of Miami/Jackson Memorial Hospital.

The patient, Danielle Press, 26, suffered life-threatening injuries in a boating accident off the coast of Key Biscayne on September 14, 2013. She was rushed to Ryder Trauma Center at the University of Miami/Jackson Memorial Medical Center with several deep, lacerating injuries to her upper leg. Trauma surgeons immediately operated on Danielle, who had lost a lot of blood and nearly died.

Doctors discovered that the sciatic nerve in her left leg, which controls the majority of movement and sensation in the leg, had been completely cut and separated. Danielle, a college graduate who taught English in South Korea, was told that she may never regain any feeling or movement in her leg as a result of the injury.

Repairing the sciatic nerve – the largest nerve in the human body – presents one of the most difficult challenges in nerve surgery, particularly when a significant gap exists, as was the case with Danielle. One of the major limiting factors in the repair of this nerve is the absence or lack of donor nerve material. Even in cases in which a relatively small gap exists, the donor nerves that are located in the lower leg that are harvested for this repair are rapidly depleted. Insufficient autologous nerves are a major obstacle to successful repair strategies for sciatic nerve injuries with large gaps like the one seen in this case.

Dr. Levi, who specializes in the field of spine and peripheral nerve surgery, considered traditional nerve grafting, but felt that Danielle may have a better outcome with alternative treatment options, such as using her own Schwann cells, expanded in number using cell culture techniques. Schwann cells are involved in many important aspects of peripheral nerve biology including the conduction of nervous impulses along axons, nerve development, and regeneration. Dr. Levi and his team are leading an FDA approved Phase 1 clinical trial as part of the University of Miami Miller School of Medicine’s Miami Project to Cure Paralysis using a patient’s own Schwann cells for acute spinal cord injuries. Pre-clinical work suggested that the use of Schwann cells could also be beneficial in Danielle’s unique case.

Dr. Levi obtained approval from the FDA for this procedure to combine standard nerve grafting with autologous human Schwann cells, with a goal of providing Danielle with an opportunity to maximize nerve regeneration and restoration of function. On October 14, Dr. Levi performed a nerve graft on Danielle using a combination of her own nerves and her own Schwann cells. This world’s first procedure was done at Jackson Memorial Hospital.

“At the University of Miami and Jackson Memorial Hospital we always provide not only the standard of care, but try to think outside the box in order to change the practice of medicine and better people’s lives,” Dr. Levi said. “We felt it was extremely important to literally utilize everything in our toolbox to make an effort to give this young lady a chance at recovering some function and sensation in her leg,”

Danielle’s parents were supportive of their daughter becoming the first patient to undergo this experimental procedure.

“The severity of Danielle’s injury doesn’t get any worse,” said Danielle’s father, Charles Press, the chief of police in Key Biscayne. “We felt this was the best option that would give her a chance for a positive outcome.”

Dr. Levi and his team believe that by combining standard nerve grafting with autologous human Schwann cells provides an opportunity to maximize nerve regeneration and restoration of function. This combination strategy for compassionate use is dictated by the severity of the current clinical case and forms the basis for this FDA approved single patient study. Enhancing the potential for nerve regeneration will potentially allow for motor and sensory recovery including protective sensation.

The medical team believed this approach, in which no viable alternative strategies exist to supplement repair, is the correct approach in implementing a new cellular strategy. Adapting the current, established FDA approved protocol of autologous human Schwann cell preparation for sub-acute thoracic SCI permitted the medical team to implement cell preparation relatively seamlessly and with considerable experience.

As a research subject, Danielle will continue to be followed for the next five years, during which time doctors will closely monitor her progress. As her condition improves, she will begin physical rehabilitation.