First FDA-Approved Autologous Schwann Cell Transplantation Performed for Acute Spinal Cord Injury

Surgeons and scientists at The Miami Project to Cure Paralysis, a Center of Excellence at the University of Miami Miller School of Medicine, have completed the first Food and Drug Administration–approved transplantation of a patient’s own Schwann cells following a new spinal cord injury. The procedure, carried out at the University of Miami/Jackson Memorial Medical Center, is part of a Phase I clinical trial that aims to evaluate the safety and feasibility of autologous Schwann cell transplantation in people with acute thoracic spinal cord injury (SCI).

“This historic clinical trial represents a major advance in a field where each progress step holds significant promise,” said neurosurgeon Barth Green, M.D., Co‑Founder and Chairman of The Miami Project and Professor and Chair of Neurological Surgery. “The work of hundreds of scientists, clinicians, and technicians has made this first‑in‑human Schwann cell transplantation possible. The commitment of time and resources to reach this milestone underscores the importance of translating laboratory discoveries into clinical treatments aimed at curing paralysis.”

Scientific leadership for the Schwann cell clinical trial is provided by W. Dalton Dietrich, Ph.D., Scientific Director of The Miami Project and Professor of Neurological Surgery, Neurology, and Cell Biology & Anatomy. The multidisciplinary team includes basic scientists, clinical faculty, laboratory staff, and regulatory specialists who collaborated to move the protocol from preclinical research to an FDA‑approved human trial. The transplantation itself was performed by the trial’s Principal Investigators, Allan Levi, M.D., Ph.D., and James Guest, M.D., Ph.D., both neurosurgeons with expertise in spinal cord injury care and surgical techniques.

Trial Design and Procedure

The Phase I study will enroll up to eight participants who sustain acute thoracic spinal cord injuries. Eligible patients are those who meet strict inclusion criteria and are admitted to the trauma center shortly after injury. Each participant undergoes a sensory nerve biopsy from one leg to obtain tissue for Schwann cell culture. These patient‑derived Schwann cells are expanded and purified in a specialized cell culture facility over three to five weeks to produce the required number of cells for transplantation.

Surgical transplantation is scheduled for when participants are between 26 and 42 days post‑injury. The process uses the patient’s own cells (autologous transplantation) to reduce the risk of immune rejection and to adhere to regulatory safety standards. In the first enrolled patient—who had a neurologically complete thoracic spinal cord injury—the transplantation was completed without reported adverse events, and the clinical team continues to monitor safety as the trial progresses.

Follow-Up and Long-Term Monitoring

All procedures and follow‑up visits are conducted at University of Miami/Jackson Memorial Medical Center and The Miami Project to Cure Paralysis, with support from colleagues at the University of Miami Miller School of Medicine. Each participant will be followed intensively for one year after transplantation with standardized assessments of neurologic function, overall medical status, pain, and muscle spasticity. Because enrollment and follow‑up occur sequentially, it is expected to take two to three years from the enrollment of the first subject until the final enrolled participant completes one year of follow‑up.

Beyond the initial one‑year evaluation, participants will continue to be monitored for an additional four years under a separate protocol to capture long‑term safety and outcomes. The safety and feasibility data collected in this Phase I trial are intended to form the foundation for future cell‑based therapeutic trials that may explore different injury levels, timing after injury, and combination therapies.

Significance for Spinal Cord Injury Research

“As a basic scientist, it is profoundly gratifying to see decades of laboratory research translated into a clinical trial that may improve lives,” said W. Dalton Dietrich, Ph.D. This trial represents more than 25 years of scientific work at The Miami Project to develop Schwann cell–based therapies. Successful completion of this first‑in‑human study would provide critical safety data and help guide the development of larger trials designed to evaluate efficacy and refine transplantation strategies for people living with spinal cord injury.

Notes about this paralysis research

Contact: Scott P. Roy – The Miami Project to Cure Paralysis
Source: University of Miami press release
Image Source: Schwann cell image adapted from an original microscopy image by Ucbtbej (own work) via Wikimedia Commons