Phase I/IIa study published in Oxford University Press’s Brain demonstrates reductions in brain immune cell density and improvements in key clinical outcomes; Department of Defense-funded Phase II trial currently enrolling in Houston and San Antonio
HOUSTON–(BUSINESS WIRE)–#biopharma–For millions of people living with the long-term effects of traumatic brain injury (TBI), the prevailing belief has been that chronic neuroinflammation causes recovery to plateau over time, meaning correspondingly few long-range care options.
New research published in the prestigious journal Brain, one of the world’s leading neurology journals, is challenging that assumption.
“Our findings suggest that chronic neuroinflammation may be a treatable target, even years after traumatic brain injury,” said Charles S. Cox, Jr., MD, principal investigator and lead author. “These results provide important justification for advancing this work into larger, controlled clinical trials.”
The study, conducted by UTHealth Houston (NCT04063215, results posted), assessed the impact of Hope Biosciences’ autologous adipose-derived mesenchymal stem cells (HB-adMSCs) in adult patients with chronic TBI using imaging, functional, and neurocognitive outcome measures. Design was a single center, open label trial for 24 adult patients living with sub-acute or chronic neurological injury at least six months established. Participants received three infusions of 200 million stem cells over a six-week period, spaced 14 days apart, with status monitored and tested for a year following last infusion.
Investigators from UTHealth Houston report treatment with HB-adMSCs was associated with reduced brain inflammation, improvements in measures of depression, fatigue, and pain, and positive changes in advanced brain imaging biomarkers among adults living with chronic TBI. Using advanced PET imaging and MRI technologies, investigators found HB-adMSC treatment correlated with significant reductions in brain immune cell density in regions linked to depression, fatigue, and pain. Brain imaging revealed improvements in measures associated with microstructural brain integrity. The study also concludes a favorable safety profile, with no serious treatment-related adverse events reported.
Hope Biosciences’ cells continue to be studied through multiple FDA-authorized protocols for brain injury, including a Phase II Department of Defense-funded clinical trial again run by UTHealth Houston and UTHealth San Antonio. The 51-patient Phase II trial is a double-blind placebo-controlled design dictating the same treatment periodicity that yielded the results presented in Brain, and is currently recruiting in Houston and San Antonio. 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 treatment cost to participate. For up-to-date clinical trial information, please watch the informational video and visit clinicaltrials.gov (NCT05951777) for site contact information.
An estimated 11.4 million American adults live with TBI-related disability. TBI has been linked with later development of dementia, including Alzheimer’s; Parkinson’s Disease; immune suppression; various psychiatric disorders; and an overall increase in mortality. There is currently no cure.
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