Autologous Adipose-Derived Mesenchymal Stem Cells for Chronic Traumatic Brain Injury

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Traumatic Brain Injury

In brief

The global objective of this study is to establish the safety and investigate the potential treatment effect of an intravenous infusion of HB-adMSCs (Hope Biosciences adipose-derived mesenchymal stem cells) on brain structure, neurocognitive/functional outcomes, and neuroinflammation after traumatic brain injury.

Key facts

Study ID

NCT05951777

Run by

Hope Biosciences LLC

People needed

51

Starts

2024-04-16

Expected to finish

2027-12-01

Last updated by the study team

2026-07-15

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults between 18 and 55 years of age.
• Documented functional neurological damage to the central nervous system from blunt force head trauma unlikely to improve with present standard of care approaches.
• A Glasgow Outcome Scale-Extended (GOS-E) score > 2 and ≤ 6.
• Onset or diagnosis of the injury or disease process greater than 6 months and ≤ 20 years.
• Ability to obtain consent from the subject or their legally authorized representative (LAR).
• Ability to verbally communicate in English or Spanish (required for validated neurocognitive outcome testing).

You may not qualify if…

• Known history of:
• intellectual deficiency or uncontrolled psychiatric conditions likely to invalidate our ability to assess changes in cognition or behavior, or at the discretion of the PI,
• recently treated infection,
• renal disease or altered renal function (screening eGFR < 60 mL/min/1.73m2),
• hepatic disease or altered liver function (screening SGPT > 150 U/L or T. Bilirubin >1.3 mg/dL),
• cancer,
• immunosuppression (screening WBC < 3, 000 cells/ml),
• Positive infectious disease tests including HIV, Hep. B, Hep. C., and Syphilis,
• chemical or ETOH dependency that in the opinion of the investigator would preclude enrollment/participation in the study,
• acute or chronic lung disease requiring significant medication/oxygen supplementation,
• bleeding disorders, thrombocytopenia, including immune-mediated heparin-induced thrombocytopenia,
• known sensitivity to heparin, Lovenox, and pork products,
• individuals with mechanical prosthetic heart valves,
• individuals who have received a stem cell treatment, gene or cellular therapy.
• Normal brain CT/MRI exam.
• Planned epidural or spinal anesthesia, or undergoing spinal puncture, complete spinal cord injury.
• Diagnosed with a genetic or metabolic disorder related to the neurologic condition.
• Other acute or chronic medical conditions that, in the opinion of the investigator, may increase the risks associated with study participation.
• For women of childbearing potential, a positive pregnancy test at the screening visit or, for both women and men, unwillingness to comply with acceptable methods of birth control during the study.
• Concurrent participation in interventional drug or device study.
• Inability to undergo the diagnostic tests (PET/DT-MRI) or unwilling/unable to cooperate with the diagnostic tests and outcome assessments.
• Metal implants including baclofen pumps that would preclude DT-MRI.
• Unwilling or unable to return for the follow-up study visits.
• Uncorrectable vision impairment that will prevent completion of neurocognitive tests require visual processing.

Where it is running

• Memorial Hermann Hospital / UTHealth McGovern Medical School at Houston — Houston, Texas, United States (enrolling)
• The University of Texas Health Science at San Antonio — San Antonio, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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