The Miami Project Launches Phase I Clinical Trial for Chronic SCI
February 2015 – At long last, we have begun our first clinical trial testing autologous human Schwann cell (ahSC) transplantation in people living with chronic spinal cord injury (SCI). This is also a Phase I trial focused on safety and feasibility outcomes. As we announced in October 2014, we obtained FDA approval after having submitted for review additional data regarding transplantation of Schwann cells into rodents and some pigs with chronic SCI. We now have ethics approval from the University of Miami Institutional Review Board and are open for enrollment.
This new trial will be primarily focused on safety, but in addition it will involve a preliminary evaluation of the efficacy of combining Schwann cells with exercise and rehabilitation. For humans with chronic SCI, we hypothesize that axons might show improved function if myelin repair is induced with the implantation of ahSC. In addition, spinal cord cavitation may be reduced and neural sprouting and plasticity may be enhanced via neurotrophic effects. In this trial, participants will receive fitness conditioning and locomotor rehabilitation prior to transplantation in order to validate the stability of their neurological baseline and enhance their ability to undergo surgery with few complications. They will also receive fitness conditioning and rehabilitation post-transplantation to maintain health and promote neuronal activity and potential neuroplasticity.
We only have FDA approval to transplant a maximum of 10 people – remember that it is a Phase I safety trial. In order to reduce risk, there are a number of inclusion and exclusion criteria. You may qualify if you have had a traumatic SCI at least 1 year ago between the spinal levels of C5-T12, if you are between the ages of 18 and 65, and you have no major health issues.
There are 5 stages of Screening to progress through before the actual Schwann cell transplantation occurs and each participant’s time commitment to the trial will be approximately 10 months. They will be followed in a separate long-term monitoring protocol annually for a total of 5 years post-transplantation.
To find out more information about the trial and pre-screening, contact The Miami Project Education Department at 305-243-7108 or MPinfo@med.miami.edu.