Using stem cells from fat to treat chronic traumatic brain injury

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

This study is testing if infusing stem cells taken from fat can help people with chronic traumatic brain injuries feel better and improve their brain function.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 51 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Hope Biosciences Research Foundation (industry)
• Locations: 2 sites (Houston, Texas and 1 other locations)
• Trial ID: NCT05951777 on ClinicalTrials.gov

What this trial studies

This Phase 2a clinical trial aims to evaluate the safety and potential efficacy of intravenous infusions of autologous adipose-derived mesenchymal stem cells (HB-adMSCs) in patients with chronic traumatic brain injury. Participants will receive three infusions over a six-week period, with assessments for safety and neurocognitive outcomes conducted at various follow-up intervals. The study employs a randomized, double-blind, placebo-controlled design to ensure robust results regarding the treatment's effectiveness and safety profile.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 55 with documented neurological damage from closed head trauma that is unlikely to improve with standard care.

Not a fit: Patients with significant psychiatric conditions or other severe health issues may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could improve brain function and quality of life for patients suffering from chronic traumatic brain injury.

How similar studies have performed: While the use of stem cells for brain injury is an emerging field, similar studies have shown promise, though this specific approach is relatively novel.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Known history of:

   1. 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,
   2. recently treated infection,
   3. renal disease or altered renal function (screening eGFR \< 60 mL/min/1.73m2),
   4. hepatic disease or altered liver function (screening SGPT \> 150 U/L or T. Bilirubin \>1.3 mg/dL),
   5. cancer,
   6. immunosuppression (screening WBC \< 3, 000 cells/ml),
   7. Positive infectious disease tests including HIV, Hep. B, Hep. C., and Syphilis,
   8. chemical or ETOH dependency that in the opinion of the investigator would preclude enrollment,
   9. acute or chronic lung disease requiring significant medication/oxygen supplementation,
   10. bleeding disorders including immune-mediated heparin-induced thrombocytopenia,
   11. known sensitivity to heparin, Lovenox, and pork products,
   12. individuals with mechanical prosthetic heart valves,
   13. individuals who have received a stem cell treatment, gene or cellular therapy.
2. Normal brain CT/MRI exam.
3. History of spinal cord injury.
4. Diagnosed with a genetic or metabolic disorder related to the neurologic condition.
5. Other acute or chronic medical conditions that, in the opinion of the investigator, may increase the risks associated with study participation.
6. 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.
7. Concurrent participation in interventional drug or device study.
8. Inability to undergo the diagnostic tests (PET/DT-MRI) or unwilling/unable to cooperate with the diagnostic tests and outcome assessments.
9. Metal implants including baclofen pumps that would preclude DT-MRI.
10. Unwilling or unable to return for the follow-up study visits.

Where this trial is running

Houston, Texas and 1 other locations

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

Study contacts

• Principal investigator: Charles S Cox, MD — The University of Texas Health Science Center, Houston
• Study coordinator: Carmen Duron, RN, MHA, BSN

Conditions: Traumatic Brain Injury, severe, intracranial hemorrhage, chronic, neurological injury