Using stem cells from fat to treat chronic traumatic brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adults between 18 and 55 years of age.
2. Documented functional neurological damage to the central nervous system from blunt force head trauma 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/participation in the study,
   9. acute or chronic lung disease requiring significant medication/oxygen supplementation,
   10. bleeding disorders, thrombocytopenia, 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. Planned epidural or spinal anesthesia, or undergoing spinal puncture, complete 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 during the study.
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.
11. Uncorrectable vision impairment that will prevent completion of neurocognitive tests require visual processing.

Where it's running

• 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
• Email: Maria.Carmen.Duron@uth.tmc.edu
• Phone: 713-500-7395

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.