Could your own fat cells heal a damaged brain?
NCT ID NCT05951777
First seen Jun 27, 2026 · Last updated Jul 16, 2026 · Updated 2 times
Summary
This study tests whether a single IV infusion of stem cells taken from a patient's own belly fat can safely improve brain structure and thinking skills after a traumatic brain injury. The trial enrolls 51 adults aged 18-55 who have had a brain injury for at least 6 months but no more than 20 years. Researchers will monitor blood tests and brain scans to see if the treatment reduces inflammation and helps repair damage.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 51 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Memorial Hermann Hospital / UTHealth McGovern Medical School at Houston
RECRUITINGHouston, Texas, 77030, United States
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The University of Texas Health Science at San Antonio
RECRUITINGSan Antonio, Texas, 78229, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a web program rebuild memory after brain injury?
- Why a simple fall can cause brain bleeding in older adults
- Bedside ultrasound could flag hidden brain injury decline
- Zapping the brain to restore lost vision
- Machine learning may forecast brain decline after head injury
- MRI tracer could expose hidden brain energy crisis after head injury