Participant selection & pre-training
Today, over 5 million people are living with some form of paralysis due to injury to the nervous system. The importance of selecting a particular SCI subject population for specific treatment strategies was highlighted early as an important step in targeting paralysis. This strategy emphasized the need to determine which subpopulation of people living with SCI might benefit the most from personalized regenerative therapies including cellular transplantation trials. Even at that time, it was clear that the SCI subject population was heterogeneous and the use of specific interventions targeting selective therapeutic targets might be critical when considering treatment strategies. Also, the need for various training and rehabilitation strategies specifically for those with chronic injuries was emphasized to ensure significant cardiovascular or skeletal integrities supporting increased function. Today, our educational and clinical trial programs have accumulated a listing of over 1400 persons living with paralysis due to SCI whom are interested in clinical trials. This secured registry contains information about injury characteristics that is useful for selecting specific subgroups of SCI for different studies. The ability to identify specific SCI groups to participate in clinical studies allows the Miami Project to conduct hypothesis driven research that provides a platform for future multicenter clinical trial with colleagues throughout the world. We acknowledge and thank all of our volunteers for participating in our research studies.
With these goals in mind, The Miami Project initiated a conditioning rehabilitation program on the first floor of the Lois Pope LIFE Center which prepares subjects for potential cell therapies including Schwann cell transplantation. The important topic of aging with paralysis has also been recently emphasized and stresses the need for good dietary and exercise programs to inhibit or reduce established co-morbidities associated with SCI including cardiovascular disease, obesity, and diabetes. On any given day of the week, individuals are working out in our 1st floor facility using specialized equipment under the supervision of our expert staff and scientists. Conditioning strategies have already been reported to improve several indicators of cardiovascular function, strength, endurance, and metabolic function. Neurorehabilitation strategies to promote locomotor and arm and hand function have been implemented using cutting edge approaches as well as state-of-the-art robotic systems. Thus, individuals can undergo a variety of multimodal tasks to enhance function that will help prepare them for the intensive rehabilitation strategies that will be required to promote healthy aging or enhance cellular and molecular processes including circuit plasticity with cellular transplantation approaches.
In this regard, a special program called “The Miami Boot Camp” has been initiated that is assessing multimodal training paradigms for future candidates for cellular transplantation treatments. Over several weeks, individuals that meet specific inclusion criteria are put through a concentrated program to monitor and improve specific outcomes such as motor function, sensory dysfunction, and endurance. It is also envisioned that similar training and neurorehabilitation approaches will be used after the transplantation procedures to enhance regenerative processes and ultimately increase treatment potential. The combining of multimodal rehabilitation approaches including a pre-and post-surgery training strategy is now a reality as we continue to move our FDA approved cell therapy programs forward.