RecruitingPhase 2NCT05951777
Official study title

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

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAutologous HB-adMSCs and Normal Saline

The study team can explain what participation involves.

Who it may be forTraumatic Brain Injury

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 15, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 2

Interventional

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?Hope Biosciences LLC

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Hope Biosciences LLC
Interventions being studied
Biological: Autologous HB-adMSCs; Drug: Normal Saline
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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).

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Memorial Hermann Hospital / UTHealth McGovern Medical School at HoustonHouston, Texas
  • The University of Texas Health Science at San AntonioSan Antonio, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 15, 2026. Always confirm current availability with the study team.

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