18 Apr Stem Cell Therapy Improved Motor Deficit in Traumatic Brain Injury Trial
MedicalResearch.com Interview with:
Dr. David Okonkwo, M.D., Ph.D.,
Professor of Neurological surgery
Director of the Neurotrauma Clinical Trials Center
University of Pittsburgh
Dr. Okonkwo discusses the results from the STEMTRA Phase 2 trial evaluating the efficacy and safety of SB623 in patients with chronic motor deficit from traumatic brain injury.
The results were presented at the American Association of Neurological Surgeons (AANS), April 2019
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Traumatic brain injury (TBI) is a major cause of death and disability in the US and around the globe. The effects of TBI are often long-lasting, with more than one-third of severe TBI patients displaying a neuromotor abnormality on physical examination 2 years following injury and, yet, there are no effective treatments. The public health implications are staggering: there are approximately 1.4 million new cases of TBI in the US annually, resulting in over 50,000 deaths and 80,000 disabilities; over 5 million Americans currently suffer from long-term disability caused by TBI. A successful neuroregenerative or neurorestorative therapy, such as stem cell implantation, would have significant impact.
MedicalResearch.com: Would you briefly explain what is meant by SB623?
Response: SanB are modified bone marrow-derived mesenchymal stem cells.
MedicalResearch.com: How are the stem cells obtained?
Response: Mesenchymal stem cells are obtained from bone marrow aspirates of healthy adult male donors. The isolated stem cells are then transiently transfected and amplified in culture to produce SB623 cells for therapeutic use.
MedicalResearch.com: What are the main findings?
Response: We implanted SB623 in adults with chronic, fixed motor deficits due to a traumatic brain injury. The primary efficacy endpoint was achieved, in that patients who received stem cell therapy experienced significant improvement at 6 months from baseline in the Fugl-Meyer Motor Scale (FMMS) compared to control patients. In addition, significantly more SB623-treated than control patients achieved threshold of ≥10 points from baseline on the FMMS at 6 months (39.1% vs. 6.7%, p=0.04), which has been considered a clinically meaningful threshold in the context of acquired brain injury. There were no significant differences in the rates of adverse events or serious adverse events in SB623-treated and control patients and there were no dose-limiting toxicities or deaths.
MedicalResearch.com: What should readers take away from your report?
Response: Stem cell therapy with SB623 cells in chronic traumatic brain injury patients with fixed motor deficits achieved the primary efficacy endpoint of the Phase 2 clinical trial, and implantation of SB623 cells appeared to be safe and well tolerated.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: SB623 cells show promise for the treatment for traumatic brain injury. This was a Phase 2 clinical trial and SB623 cells, as an investigational product, requires further clinical development.
Any disclosures? I have no financial or business relationships to disclose.
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