FDA-authorized Phase II trial, conducted by UTHealth Houston and utilizing Hope Biosciences’ proprietary autologous stem cells, now enrolling participants with chronic traumatic brain injury in Houston and San Antonio

Enrollment has opened at UTHealth San Antonio for a 51-participant, FDA-authorized double-blind placebo-controlled Phase II clinical trial to evaluate if intravenously infused Hope Biosciences autologous, adipose-derived mesenchymal stem cells (HB-adMSCs) affect brain structure, neurocognitive and functional outcomes, and/or neuroinflammation after traumatic brain injury (TBI) in adults.

The Department of Defense (DoD)-funded trial is now underway in Houston and San Antonio and marks the second collaboration between UTHealth Houston and industry partner Hope Biosciences. Preliminary results of a previously completed 24-patient open label Phase I/IIa study yielded clinically significant effects in imaging biomarkers, and patient-reported outcomes.

“We are very encouraged by the Phase I results,” elaborates Dr. Charles Cox, Principal Investigator, UTHealth Houston. “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.”

Participants can be aged 18 to 55 years, with functional damage from closed head trauma unlikely to improve with present standards of care. Diagnosis must be greater than six months, with a Glasgow Outcome Scale-Extended score greater than “2” and less than or equal to “6.” There is no cost to participate.

“This larger Phase II trial dictates the same protocol that previously yielded results – three infusions of approximately 200 million autologous stem cells cultured through our proprietary technology, administered over a six-week period and spaced 14 days apart,” explains Donna Chang, CEO, Hope Biosciences. “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.”

TBI is currently considered incurable. An estimated 5.3 million people live with permanent TBI-related disability in the U.S., including more than 460,000 military service members diagnosed since 2000.

For up-to-date clinical trial information, please watch the informational video and visit clinicaltrials.gov (NCT05951777) for site contact information.

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"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." - Dr. Charles Cox