The National Institute of Biomedical Imaging and Bioengineering, which is the primary funding agency for spinal cord stimulation – convened a meeting In Washington DC of stakeholders in the field. Reggie Edgerton, of UCLA, and Susan Harkema, from Louisville, presented a brief “results so far” discussion. Several Food and Drug Administration (FDA) operatives were there, and were said to be accommodating as far as moving trials and reviews ahead.
At this gathering there was talk about mechanisms of action (how the stim works), about primary and secondary outcomes; potential for seeing a significance change in bladder, bowel, sexual, temperature, autonomic dysreflexia, and movement; inclusion and exclusion criteria for potential patient populations.
Industry perspectives were presented by representatives from Medtronic, St. Jude Medical and Boston Scientific, the three large corporations that comprise the bulk of the spinal cord stimulation market (pain only at this time) attended. They, of course, may sense a market forming but unfortunately, none of them have shown interest in pursuing any R&D specific to SCI.
Meanwhile, Joel W. Burdick, PhD, California Institute of Technology (CalTech) and Nicholas Terrafranca, Jr., DPM, attended; they are co-founders, with Edgerton, of Los Angeles based NeuroRecovery Technologies, Inc. They are, of course, very keen on a commercial future for spinal cord stimulation, and have the patents from UCLA, CalTech and the University of Louisville to bring a new generation stimulator to market. However, they also unfortunately have not been able to acquire any venture capital.
Lyn Jakeman, PhD, Program Director, National Institute of Neurological Disorders and Stroke attended, as did her predecessor at NINDS, Naomi Kleitman, PhD. Out of this gathering NIBIB formed a grouping interested in Addressing Paralysis through Spinal Stimulation Technologies. The goal is “to establish a national coordinated partnership of stakeholder investigators and organizations for the purpose of advancing the deployment of existing technologies for the treatment of dysfunctions in spinal cord injuries.” Unfortunately, it’s not clear just what the grouping will accomplish but the NIBIB says it may possibly could do the following:
– initiate collaboration among all key stakeholders in their effort to examine and apply the spinal stimulation technologies to improve the outcomes in dysfunctions in spinal cord injuries;
– create a national plan of action that coordinates the efforts of all stakeholders, aligns resources for their most effective utilization, avoids unnecessary duplication of effort, encourages the greatest degree of cooperation among researchers and their organizations, accelerates program development, and achieves results;
– foster development of clinical trial protocols that lead to adoption of the most effective best practices for the treatment and care of individuals with spinal cord injury;
– eventually create a self-sustaining National Coalition of scientists, clinical researchers, academic institutions, industry, government agencies, and not-for-profit foundations to sustain the initiative for developing a new safe and effective intervention for spinal cord injury which will result in improve functional outcomes and quality of life.
We’ll have to wait and see if anything actually comes of NIBIB involvement in future years pending grant awards and better overall research results. Stay tuned…in the coming years I’ll report if any progress is made by the NIBIB here at this SCI Research and Advocacy blog.