A research team led by Charles S. Cox, Jr., M.D., at The University of Texas Health Science Center at Houston (UTHealth) has been awarded $6.8 million from the U.S. Department of Defense (DOD) to assess the safety and efficacy of using autologous stem cell therapy in adults with emergent traumatic brain injury.
Memorial Hermann-Texas Medical Center is the site for the study.
"The DOD award will fund our next phase of clinical trials using cellular therapy for severe traumatic brain injury and we are gratified to see continued progress supported by our partners in the Joint Warfighter Program," said Cox, the George and Cynthia Mitchell Distinguished Chair in Neurosciences at UTHealth, professor in the Department of Pediatric Surgery and co-director of the Memorial Hermann Red Duke Trauma Institute. "This trial is designed to move past merely testing safety, but to also determine if there are structural improvements in the brain."
According to the Centers for Disease Control, 1.7 million Americans sustain a traumatic brain injury (TBI) annually. Of those, 275,000 are hospitalized and 52,000 die. TBI is a contributing factor to a third of all injury-related deaths in the country.
"We are very proud of Dr. Cox and colleagues for their potentially game-changing work," said Barbara J. Stoll, M.D., dean of McGovern Medical School at UTHealth and H. Wayne Hightower Distinguished Professor in the Medical Sciences. "The DOD has recognized the importance of this research aimed at improving short- and long-term outcomes for patients with traumatic brain injury."
There are few current therapies to treat TBI. Critical care teams work to stabilize patients and surgery is sometimes necessary to remove or repair damaged blood vessels or tissue, as well as provide relief from swelling.
To potentially open a new avenue of treatment, Cox has been researching cell therapy for neurological disease in pre-clinical and clinical trials for more than two decades. The new study builds on his previously published research showing that autologous stem cell therapy after TBI is safe and reduces the therapeutic intensity requirements of neurocritical care. The theory is that the stem cells work in the brain to alleviate the body's inflammatory response to the trauma.
A total of 55 patients who have experienced traumatic brain injuries within the past 48 hours will be enrolled in the Phase 2, randomized, placebo-controlled study, which will determine if intravenous infusion of a patient's own stem cells results in structural preservation of gray matter and white matter, as well as select regions of the brain linked to neurocognitive function. Secondary outcomes include improvements in function (Glascow Outcome Scale) and markers of inflammation.
"The data will also help determine if these structural findings correlate with a dampening of the neuroinflammatory response to TBI," Cox said.
Patients whose traumatic brain injuries occurred more than 48 hours before arrival at the emergency center will not be eligible for the study.
UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT HOUSTON