Do you or a loved one live with Traumatic Brain Injury (TBI)?
Enrollment has begun for a 51-participant, FDA-authorized 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 TBI in adults.
Come along with the Hope Biosciences team to learn what this trial means for you or your loved one, including an explanation of terms in plain language, an overview of the study schedule and design, and a full explanation of the investigational product for TBI patients, families, and caregivers. Hear directly from Principal Investigator Dr. Charles Cox, UTHealth Houston, about results from a recently completed Phase I clinical trial, how stem cells act in the body, and what metrics he and his team will monitor in the current Phase II trial.
The study, led by UTHealth Houston and industry partner Hope Biosciences, is funded by the U.S. Army Medical Research and Development Command (USAMRDC). Support of $4.9M was granted at the recommendation of scientist reviewers, who lauded the project’s potential to fill a current void in effective interventions for chronic TBI and noted potential for major impact on military health, including combat-incurred blast injuries, as well as civilian mechanisms such as motor vehicle crashes, falls, and other impacts.
Fifty-one participants from two clinical sites in Houston (currently recruiting) and San Antonio (recruiting soon), Texas. Participants can be male or female, between 18 and 55 years of age, with functional damage from closed head trauma unlikely to improve with present standard of care approaches. Onset or diagnosis must be greater than six months, with a Glasgow Outcome Scale-Extended score greater than “2” and less than or equal to “6.” Participants must be able to communicate in English or Spanish. There is no cost to participate.
For complete trial listing, including contact information, please see ClinicalTrials.gov (NCT05951777) - clinicaltrials.gov/study/NCT0...
Clinical Trial Updates:
This informational video was published June 17th, 2024. Please watch this space for enrollment and other updates as they occur. Thank you!
Houston Site: Actively recruiting. Please contact Carmen Duron at 713-500-7395 or Maria.carmen.duron@uth.tmc.edu
San Antonio Site: Pending.