THE MIAMI PROJECT TO CURE PARALYSIS: CURRENT STUDIES TARGETING THERAPEUTIC HYPOTHERMIA AND SCHWANN CELL TRANSPLANTATION
The Miami Project to Cure Paralysis is a Center of Excellence at the University of Miami Miller School of Medicine. For the last 25 years, scientists and clinicians working together in a multidisciplinary program have made a number of contributions to the field of CNS injury and repair. Researchers have been assessing the beneficial effects of therapeutic hypothermia (moderate systemic hypothermia)in experimental models of severe spinal cord injury with encouraging results. Cooling animals after thoracic or cervical spinal cord injury promotes behavioral improvement and reduces the amount of damage in both gray and white matter structures. Based on these encouraging preclinical studies, these investigations have been translated to the clinic. Over the last two years, members of the Department ofNeurological Surgery and The Miami Project have utilized this experimental therapy in over 30 patients with severe cervical spinal cord injury. Published data indicate that this experimental therapy appears to be safe and effective in enhancing functional recovery at one year. Based on these results, we are now moving forward to initiate a 17-center randomized multicenter trial to critically evaluate the beneficial effects of this potentially exciting new therapy to limit the devastating consequences of acute spinal cord injury. In addition to neuroprotective strategies, scientists at The Miami Project for many years have been investigating the potential use of Schwann cells to repair and promote functional recovery following acute as well as chronic spinal cord injury. Numerous studies have indicated that transplantation of Schwann cells can protect cells from dying, enhance circuit plasticity, as well as lead to myelination of demyelinated fibers. Based on encouraging findings from several models of spinal cord injury, we have now submitted an IND to the FDA to seek permission to conduct first-in-man autologous human Schwann cell transplantation in sub-acute spinal cord injured patients. In this Phase I study, a dose escalation approach will be used to evaluate safety in this patient population. This lecture will summarize these and other programs currently active in The Miami Project to Cure Paralysis.