The Miami Project to Cure Paralysis Charts Recent Scientific Progress
For The Miami Project to Cure Paralysis, a Center of Excellence at the Miller School of Medicine, 2014 has been a banner year. Its researchers have been using a bench-to-bedside-and-back-again approach to more efficiently share the findings of their advanced discovery science, translational studies, clinical investigations and FDA-approved trials.
“This is the golden age of neuroscience, and cutting-edge cellular and molecular approaches are allowing new questions to be asked and providing opportunities that have never existed before,” said W. Dalton Dietrich, Ph.D., Scientific Director, Kinetic Concepts Distinguished Chair in Neurosurgery, Senior Associate Dean for Discovery Science and professor of neurological surgery, neurology, and cell biology and anatomy.
“Although many challenges exist, I am truly excited about what we are accomplishing today. I believe that if we continue to conduct high quality research and maintain our focus on the ultimate goal, we will make a difference in lives of people living with paralysis.”
Now, as The Miami Project prepares for its Great Sports Legends Dinner on September 29 — an annual event that raises millions of dollars in research support — it takes pride in the number of projects moving through the discovery pipeline. Five FDA-approved clinical trials and various clinical studies are recruiting subjects for treatments targeting specific consequences of neurotrauma:
• A Phase 1 safety trial is evaluating a novel cellular therapy involving transplantation of millions of Schwann cells into subjects with subacute spinal cord injuries.
• A single-subject trial is also using an experimental Schwann cell bridging approach combined with nerve grafts to promote axonal regeneration and a return of leg function.
• Deep brain stimulation approaches are being evaluated for the first time to target neuropathic pain in spinal cord injury subjects.
• An FDA-approved brain-machine interface program is merging biological and biomedical disciplines to bypass the injured spinal cord and enable individuals to move their upper extremities.
• A recently approved single-subject trial is testing the therapeutic effect of adult mesenchymal stem cells following spinal cord injury.
In addition, based on new safety data, a request has been submitted to the FDA to test Schwann cell therapy in chronically injured subjects.
Investigators are also testing acute-critical-care protocols that incorporate the latest monitoring approaches, multi-model rehabilitation strategies and programs in education and outreach. Therapeutic hypothermia, for example, which was first discovered by University of Miami researchers, has been successfully used in patients with severe brain and spinal cord injuries, and future multicenter trials are anticipated.
The Miami Project is developing whole-life strategies to maximize function and good health in subjects. Educational and outreach programs provide information to thousands of people each year on the latest research findings and clinical studies targeting spinal cord injury.
Several clinical programs, such as the Miami Project “Boot Camp,” are investigating other aspects of spinal cord injury to improve function and quality of life. The goal is to combine state-of-the-art rehabilitation and conditioning strategies with powerful cellular treatments and other emerging regenerative approaches to target fitness, motor recovery, neuropathic pain, male fertility, spasticity and bladder function.