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Could your own fat cells help heal a traumatic brain injury?
NCT ID NCT04063215
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether stem cells taken from a patient's own fat and given by IV are safe and might help the brain heal after a traumatic brain injury. 24 adults with long-term brain damage received the treatment. Researchers checked vital signs and measured inflammation markers to see if the therapy could improve brain structure and thinking skills.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- stem cells from the patient's own fat
- What this could lead to
- If it works, this could point toward a treatment that helps repair brain damage and improve function after traumatic brain injury.
- What could go wrong
- This is an early, small trial (24 people) focused mainly on safety. It may not show clear benefit, and results may not apply to everyone with brain injury.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
24 people
The number who actually took part.
- Started
-
Jan 2020
- Finished
-
Oct 2024
- Lead sponsor
-
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
-
18 to 55 years
- Sex
-
Anyone
- Healthy volunteers
-
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 head injury with functional neurological damage to the central nervous system 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 5. ability to obtain consent from the subject of their legally authorized representative (LAR) 6. ability to speak English or Spanish \*required for validated neurocognitive outcome testing) - Exclusion Criteria: 1. known history of: 1. intellectual deficiency or psychiatric conditions likely to invalidate our ability to assess changes in cognition or behavior, 2. recently treated infection, 3. renal disease or altered renal function (screening serum creatinine \> 1.5 mg/dL), 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. HIV+, 8. chemical or ETOH dependency that in the opinion of the investigator would preclude participation in the study, 9. acute or chronic lung disease requiring significant medication, oxygen supplementation, or mechanical ventilation, 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. 2. Normal brain CT/MRI exam 3. Spinal deformity, spinal surgery (including repeated epidural or spinal punctures), or spinal cord injury diagnosed by CT/MR or clinical exam 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 child bearing 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. participation in a concurrent interventional study 8. inability to undergo the diagnostic tests (PET/DT-MRI) or unwilling/unable to cooperate with the diagnostic tests and outcome assessments 9. unwilling or unable to return for follow-up study visits -
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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.
Contacts and locations
Locations
-
Memorial Hermann Hospital-Clinical Research Unit (MMH-CRU)
Houston, Texas, 77030, United States
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