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This year has already been one of the most exciting 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 subacute (recent) spinal cord injury (SCI), Miami Project scientists and clinicians received ethics permission from the University of Miami Miller School of Medicine to begin enrollment for this important trial. In November we recruited our first subject and in December successfully transplanted millions of his own Schwann cells into the injury. The operation went smoothly, and we are in the process of recruiting our next subjects. This critical dose escalation safety trial will provide a basis for future trials where subjects with chronic paralysis (those paralyzed for a year or more) will be treated with this novel cell therapy. These are very exciting times for The Miami Project scientific community as we continue to translate our discoveries into people to make a difference in their lives. We greatly appreciate the support of our donors and scientific colleagues who are helping to provide critical resources as we continue to move our investigations forward.
As previously mentioned, in the near future, we plan on extending these cell therapies to subjects with chronic SCI. 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 an exciting Boot Camp in The Miami Project that will help condition and train selected individuals to maximize their chances of having a good result with the cell therapies. Thus, a series of approaches including dietary considerations, conditioning regimens, and neurorehabilitation strategies are being combined to maximize improvements in function. The Miami Project has recently obtained a state-of-the-art eLegs robotic exoskeleton for walking and we are investigating its utility for rehabilitation, conditioning, or as a mobility device in people living with paralysis. We feel that Schwann cell transplantation and subsequent combination approaches, together with these conditioning and rehabilitation strategies, may be an exciting future therapeutic to make a meaningful difference to people living with the SCI.
The Miami Project is also beginning to work more closely with various biotech companies to help translate some of their products and discoveries to the paralysis population. A recent development is our work with Medtronics 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 approaches for deep brain stimulation are also proving advantageous in promoting sensory and motor function in animal models of SCI and a clinical trial will begin this year targeting unresponsive pain in chronically injured individuals. Our ultimate goal will be to combine exciting biomedical and rehabilitation approaches with biological therapies to maximize repair and recovery processes.
The Miami Project scientists continue to receive new funding from various spinal cord foundations, as well as the National Institutes of Health and the Department of Defense (DoD). Many of the discoveries and clinical studies that we are testing in the civilian population are relevant to our military personnel who also have a high incidence of SCI and traumatic brain injury (TBI). Indeed, new DoD funding is currently supporting studies on the detrimental effects of repetitive concussion that may occur in individuals during various sporting events as well as in war situations throughout the world. A new multi-center therapeutic hypothermia trial is being initiated that will test for the first time whether mild cooling prior to decompression surgery in patients with severe TBI can have dramatic effects on improving outcome. Again, these are excellent examples of how discoveries within The Miami Project are being successfully translated to our patient populations.
Currently, there are limited pharmacological agents that can be used to protect the injured spinal cord from secondary injury mechanisms. A variety of drug therapies have failed to show significant benefits in the acute SCI populations. Our drug discovery program has identified novel molecules and cell signaling pathways that promote axonal regeneration better than currently available agents. Miami Project scientists also continue to investigate the therapeutic effects of hypothermia in patients with acute cervical SCI. A total of 35 participants have now been treated with therapeutic hypothermia and current results appear to be extremely encouraging. Indeed, at one year following injury, a significant percentage of conversion from complete paralysis to incomplete paralysis is being seen in the cooled population. Our scientists and clinicians are submitting multi-center trial grant applications to rigorously test the benefits of therapeutic hypothermia in this patient population as well.
We continue to concentrate on various quality of life issues that are important to people living with paralysis. Fertility problems in men living with SCI continue to be investigated and a new clinical trial testing a novel therapeutic target is being conducted. Another important quality of life issue involves the high incidence of neuropathic pain that is seen in our subjects living with paralysis. Clinical studies are underway to evaluate various factors that influence neuropathic pain. The Project continues to represent 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. This issue of our magazine covers all of our research endeavors and accomplishments during 2012 and highlights advances in many of our programs. 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. 2013 is already turning out to be a special year, and we thank everyone for their support.
With all my warmest regards and gratitude,
Barth A. Green, M.D., F.A.C.S.
Professor and Chairman, Department of Neurological Surgery
Chairman, The Miami Project to Cure Paralysis