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This year has been the most exciting to date in the history of The Miami Project to Cure Paralysis. We have obtained five FDA-approved clinical trials targeting spinal cord injury. Our Phase 1 safety trial to evaluate autologous human Schwann cell transplantation in subacute injury subjects is ongoing. We have successfully transplanted millions of Schwann cells into three subjects. We have submitted new data to the FDA to seek permission to test this therapy in chronically injured individuals. Another FDA approved trial using Schwann cells targets peripheral nerve injury to promote regeneration. One subject has been treated and is recovering. Deep brain stimulation is being evaluated for the first time to target neuropathic pain in spinal cord injured subjects. This FDA approved program will provide new strategies for targeting this quality of life issue. Our brain-machine interface FDA approved program is merging biological and biomedical disciplines to allow individuals to move their upper extremities thereby enhancing independence. Finally, a trial to test the efficacy of adult mesenchymal stem cells has been approved by the FDA for a single subject. Together these trials represent the most comprehensive program in the world testing experimental therapies for spinal cord injury.
The beneficial effects of therapeutic hypothermia in our patient populations with brain and spinal cord injury continue to be demonstrated. Treated spinal cord individuals are showing long term benefits. A specific group of severe brain injured subjects that may benefit most from early cooling has been identified. These neuroprotection programs are examples of how basic and translational studies have been successfully moved into the clinic.
Multiple clinical programs including our Miami Project “Boot Camp” are actively investigating other aspects of spinal cord injury that may also improve function. Our ultimate goal is to combine the state-of-the-art rehabilitation and conditioning strategies with cell therapies and other regenerative approaches to target functional recovery, neuropathic pain, male fertility, spasticity and bladder function. The Miami Project is committed to developing whole life strategies that can maximize quality of life and good health as our scientists continue to strive to develop new therapeutic interventions.
Discovery research which fuels our translational and clinical programs is discovering new molecular and cellular mechanisms underlying cell death, axonal regeneration, and circuit repair. Ultimately, this knowledge will be combined with our current therapeutic interventions to maximize functional recovery. The clarification of critical gaps in our knowledge regarding axonal regeneration and circuit plasticity will improve our chances of developing successful cures for paralysis.
The Miami Project to Cure Paralysis was established in 1985 to develop novel therapies to improve function in paralyzed individuals. Most recently, our discoveries have been successfully translated to people and are changing the way we provide clinical care. Our program is indeed unique in that it continues to concentrate on multiple areas of medical research including education, discovery, translational and clinical trials. These are indeed exciting times within The Miami Project and we thank our friends, colleagues, and research participants for their long-term support and commitment to our research.
Barth A. Green, M.D., F.A.C.S.
Professor and Chairman, Department of Neurological Surgery
Chairman, The Miami Project to Cure Paralysis