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This year has been the most productive to date in the history of The Miami Project to Cure Paralysis. Following approval from the FDA to initiate a Phase I Safety Trial in people with recent spinal cord injury (SCI), Miami Project researchers received ethics permission from the University of Miami Miller School of Medicine and begin enrollment for this important trial. We have transplanted two subjects with millions of their own Schwann cells. These are indeed very exciting times for The Miami Project scientific community as we translate our discoveries into people to make a difference in their lives.
Based on encouraging preclinical studies, it appears that Schwann cell transplantation also represents a logical cellular approach to repairing the nervous system years after the primary insult. To maximize our chances of seeing improvements in chronically injured SCI subjects, we have initiated a Boot Camp program in The Miami Project to condition and train selected individuals to maximize their chances of benefiting from the cell therapies. We feel that Schwann cell transplantation and subsequent combination approaches, together with neurorehabilitation strategies, may be an exciting approach to making a difference in the lives of people living with SCI.
The Miami Project is also beginning to work more closely with biotech companies to help translate some of their new products and discoveries to the paralysis population. Our work with Medtronics is moving forward to test a state-of-the-art brain-machine interface to enhance upper extremity function in people with chronic cervical SCI. Brain signal processing and electrical monitoring equipment along with muscle stimulators will allow commands from the brain to be transmitted to upper extremity muscles to enhance motor function in selected subjects. New applications for deep brain stimulation are also proving advantageous in promoting sensory and motor function in models of SCI and a clinical trial is beginning to target unresponsive pain in chronically injured individuals.
Our innovative drug discovery program has identified novel molecules and therapeutic targets that promote axonal regeneration better than currently available agents. Miami Project scientists also continue to investigate the beneficial effects of therapeutic hypothermia in patients with acute SCI and traumatic brain injury (TBI). We are now positioned to initiate multi-center trials to rigorously test the benefits of therapeutic hypothermia in these two patient populations. The detrimental effects of repetitive brain concussion that can occur during sporting events are also being evaluated in human studies. Again, these are excellent examples of how discoveries within The Miami Project are being successfully translated to our patient populations.
We continue to concentrate on secondary SCI complications such as neuropathic pain, male infertility, muscle spasticity and cardiovascular disorders that are important to the quality of life of people living with paralysis. The Project represents a unique scientific environment by which discovery, translational, and clinical research comes together with the ultimate goal of advancing new therapies to protect and promote recovery in our SCI population. 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 programs.
W. Dalton Dietrich, Ph.D.
The Miami Project to Cure Paralysis
Kinetic Concepts Distinguished Chair in Neurosurgery
Senior Associate Dean for Discovery Science
Professor of Neurosurgery, Neurology, and Cell Biology & Anatomy
Vice-Chair for Research, Neurological Surgery
University of Miami Miller School of Medicine