Findings from a cellular therapy clinical trial indicate that treating patients with traumatic brain injury (TBI) using their own stem cells may reduce the neuroinflammatory response to trauma and also preserve brain tissue. The work is significant because few therapies currently exist to treat the effects of TBI, now sustained by some 1.7 million Americans each year, and over 6.5 million experience the ongoing effects of physical, cognitive, and psychosocial deficit from TBI. Principal investigator Charles Cox, MD, chair in neurosciences at University of Texas Health Science Center, Houston, commented, “The data derived from this trial moves beyond just testing the safety of this approach. We now have a hint of a treatment effect that mirrors our preclinical work, and we are now pursuing this approach in a Phase 2b clinical trial.” The findings are published online in the journal STEM CELLS.
The trial enrolled 25 patients divided between a treatment group and controls, the former of which received bone marrow harvesting, cell processing, and reinfusion within 48 hours of injury. Outcomes were assessed using MRI and diffusion tensor imaging of white brain matter. The results showed structural preservation of regions correlating to functional outcomes, as well as reduction in key inflammatory cytokines. From the article abstract: “Treatment of severe, adult traumatic brain injury using an intravenously delivered autologous bone marrow mononuclear cell infusion is safe and logistically feasible.”
Read more about the research findings here.
The journal abstract may be read here.
Posted on November 8, 2016