UTHealth Houston and Hope Biosciences have opened enrollment for a Phase II, double-blind, placebo-controlled clinical trial investigating the effects of autologous, adipose-derived mesenchymal stem cells (HB-adMSCs) in adults with chronic traumatic brain injury (TBI).
The trial, authorized by the FDA and funded by the Department of Defense (DoD), is enrolling up to 51 participants in Houston and San Antonio. TBI is considered incurable, with an estimated 5.3 million people in the U.S. living with permanent TBI-related disabilities. Since 2000, more than 460,000 U.S. military service members have been diagnosed with TBI.
The study will assess whether intravenously infused HB-adMSCs impact brain structure, neurocognitive and functional outcomes, or neuroinflammation following TBI. Eligible participants are adults aged 18 to 55 with functional impairment from closed head trauma that is unlikely to improve with current standards of care. Participants must have a diagnosis older than six months and a Glasgow Outcome Scale-Extended score between 3 and 6. There is no cost to participate.
Preliminary results from a previous 24-patient open-label Phase I/IIa study showed clinically significant effects in both imaging biomarkers and patient-reported outcomes.
Dr. Charles Cox, Principal Investigator at UTHealth Houston, stated, “We think the infusion of these cells alters the inflammatory response to injury, downregulating it so that repair responses in the body are allowed to occur and damaged neural pathways are able to come back online over time. We use very specific tools to measure microstructural changes in the brain and are eager to see results in this Phase II trial.”
The current trial follows the same protocol as the earlier study, administering three infusions of approximately 200 million autologous stem cells, cultured using Hope Biosciences’ proprietary technology, over a six-week period with each dose spaced 14 days apart.
Donna Chang, CEO of Hope Biosciences, explained, “We hope to once again demonstrate that our primary technological advantage – repeatable access to high doses of fresh stem cells – opens the door to an efficacious solution for TBI, even chronic and severe cases.”
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