The Miami Project’s Research Progress Update
August 2014 – 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.
- Another FDA approved trial is using Schwann cells targets peripheral nerve injury to promote regeneration. Only one subject has been approved for treatment, and that treatment has occurred and is being monitored. This experimental bridging approach was combined with nerve grafts targeting return of leg function.
- Deep brain stimulation (DBS) is being evaluated for the first time to target neuropathic pain in spinal cord injured subjects. Our first subject was successfully treated. This FDA approved program will provide new strategies for targeting this quality of life issue after CNS Injury.
- Our brain-machine interface FDA approved program is merging biological and biomedical disciplines with the end goal of enabling individuals to move their upper extremities thereby enhancing independence.
- Another single subject approval from the FDA is testing the effect of adult mesenchymal stem cells; the subject has been transplanted and is being monitored.
We have submitted new data to the FDA in July for a new Phase 1 trial to test autologous human Schwann cell transplantation combined with rehabilitation in chronically injured individuals for the first time. We are waiting to hear back regarding starting this phase of our trial.
The beneficial effects of therapeutic hypothermia in our patients 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 and a multi-center trial is now underway. These neuroprotective and reparative programs are examples of how basic and translational studies have been successfully moved into the clinic.
Several additional clinical programs including our Miami Project “Boot Camp” are actively investigating other aspects of spinal cord injury that may also improve function and quality of life, such as fitness, spasticity, and pain. 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 function and good health as our scientists continue to strive to develop new therapeutic interventions.
An important quality of life issue for men living with SCI is infertility. Miami Project scientists have determined the underlying cellular mechanisms underlying this problem and developed new treatment strategies that have resulted in successful fertility programs throughout the United States.
We are working with a company, Stem Cells Inc., as part of a multi-center Phase 2 trial to test their experimental stem cell therapy in people living with cervical SCI.
Together these trials represent the most comprehensive program in the world testing experimental therapies for people living with spinal cord injuries.
Discovery research which fuels our translational and clinical programs is uncovering new molecular and cellular mechanisms underlying cell death, axonal regeneration, scar formation, and circuit repair. Ultimately, this knowledge will be combined with our current therapeutic interventions to maximize functional recovery.
Our Educational and Outreach Programs are providing critical information to people regarding the latest findings and clinical studies targeting SCI. We are reaching thousands of people each year to help them identify the best treatments for their particular situations.
Our scientists and clinicians are internationally known and interact with colleagues and other institutions throughout the world to attack this complicated problem of paralysis.
Each year we are publishing over 100 new scientific and clinical articles in the top peer-reviewed journals describing our new findings to help move this exciting field forward.
We are also training the next generation of scientists and clinicians who will dedicate their scientific careers to medical research directed to successfully treating 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. The Miami Project has already made a difference in the lives of thousands of people with brain and spinal cord injury. Our ultimate goal is to develop and test safe strategies that can improve function and quality of life of all people living with all forms of paralysis.