January 23, 2013 – Doctors at The Miami Project to Cure Paralysis, a Center of Excellence at the University of Miami Miller School of Medicine, performed the first-ever Food and Drug Administration approved Schwann cell transplantation in a patient with a new spinal cord injury. The procedure, performed at the University of Miami/Jackson Memorial Medical Center, is a Phase 1 clinical trial designed to evaluate the safety and feasibility of transplanting the patient’s own Schwann cells.
“This historic clinical trial represents a giant step forward in a field of medicine where each tangible step has tremendous value. This trial, and these first patients in this trial specifically, are extremely important to our mission of curing paralysis,” said neurosurgeon Barth Green, M.D., Co-Founder and Chairman of The Miami Project, and Professor and Chair of Neurological Surgery. “The Miami Project team includes hundreds of scientists, clinicians, and technicians who have joined hands to make the ‘impossible possible,’ for which this trial is a key goal and dream now being realized. This achievement reaffirms that the tens of millions of dollars and the incalculable work hours were well invested in this first of a kind human Schwann cell project.”
Led by W. Dalton Dietrich, Ph.D., Scientific Director of The Miami Project and Professor of Neurological Surgery, Neurology and Cell Biology & Anatomy, the Schwann cell clinical trial team at The Miami Project is composed of a multi-disciplinary group of basic science and clinical faculty members, scientific staff, and regulatory personnel focused on advancing the trial. The transplantation procedure was conducted by the Principal Investigators of the trial, Drs. Allan Levi, M.D., Ph.D., Professor of Neurological Surgery, Orthopedics, and Rehabilitation, and James Guest, M.D., Ph.D., Associate Professor of Neurological Surgery. The patient had a neurologically complete thoracic spinal injury and received the transplantation of autologous Schwann cells about four weeks post-injury. There have been no adverse events and the team is moving forward with the trial.
“As a basic scientist, the hope is always to increase knowledge and discovery,” said Dietrich. “Not every day are you able to see that translated into the clinical realm with the hopes of bettering the lives of those suffering, so this Phase I clinical trial is a vital step for the field of SCI research, and for The Miami Project team that has been working diligently on this therapeutic concept for more than a quarter of a century. This trial, when completed successfully, will lay the critical foundation for future cell-based therapies to target spinal cord injuries.”
The Miami Project clinical trial will enroll a total of eight participants with acute thoracic SCI. Newly injured patients brought to the trauma center would have to meet the stringent inclusion criteria. The participants will undergo a biopsy of a sensory nerve in one leg to obtain the tissue from which to grow their own Schwann cells. The Schwann cells are then grown in a state-of-the art culturing facility for three to five weeks to generate the number of cells necessary for transplantation, and to undergo the strict purification process. By the time the Schwann cells are surgically transplanted into the injury site, participants will be 26-42 days post-injury.
All procedures will be conducted at UM/Jackson and The Miami Project to Cure Paralysis, with colleagues at the University of Miami Miller School of Medicine. Each participant will be followed intensively for one year after receiving the transplantation surgery, and their neurologic status, medical status, pain symptoms, and muscle spasticity will be evaluated. It is expected that it could be two to three years from the time the first subject is enrolled until the final subject is one year post-transplantation. All participants will continue to be monitored for an additional four years under a separate clinical protocol. This Phase I trial is the foundation upon which The Miami Project will develop future cell transplant trials targeting different types of injuries, times post-injury, and therapeutic combinations.