Recruiting
Phase 2

Autologous Adipose-Derived Mesenchymal Stem Cells

Sponsor:

Hope Biosciences LLC

Code:

NCT05951777

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Autologous HB-adMSCs

Normal Saline

Study Details

Brief 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.

Conditions

Traumatic Brain Injury

Study ID

NCT05951777

Start date

Apr 16, 2024

Status verified date

Jul, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

51 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

Autologous Adipose Derived Mesenchymal Stem Cells

placebo comparator: Placebo

Normal Saline

Interventions

Autologous HB-adMSCs

Hope Biosciences autologous adipose-derived mesenchymal stem cells

Normal Saline

Sterile Saline Solution 0.9%

Primary outcome measure

  • Glucose [ Time Frame: Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion ]
  • Calcium [ Time Frame: Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion ]
  • Albumin [ Time Frame: Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion ]
  • Total Protein [ Time Frame: Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion ]
  • Sodium [ Time Frame: Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion ]
  • Total carbon dioxide [ Time Frame: Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion ]
  • Potassium [ Time Frame: Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion ]
  • Chloride [ Time Frame: Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion ]
  • BUN (blood urea nitrogen) [ Time Frame: Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion ]
  • Creatinine [ Time Frame: Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion ]
  • Alkaline phosphatase [ Time Frame: Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion ]
  • Alanine aminotransferase [ Time Frame: Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion ]
  • Aspartate aminotransferase [ Time Frame: Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion ]
  • Total Bilirubin [ Time Frame: Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion ]
  • White blood cell [ Time Frame: Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion ]
  • Red blood cell [ Time Frame: Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion ]
  • Hemoglobin [ Time Frame: Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion ]
  • Hematocrit [ Time Frame: Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion ]
  • Mean corpuscular volume [ Time Frame: Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion ]
  • Mean corpuscular hemoglobin [ Time Frame: Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion ]
  • Mean corpuscular hemoglobin concentration [ Time Frame: Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion ]
  • Red cell distribution width [ Time Frame: Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion ]
  • Neutrophils [ Time Frame: Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion ]
  • Lymphocytes [ Time Frame: Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion ]
  • Monocytes [ Time Frame: Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion ]
  • Eosinophils [ Time Frame: Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion ]
  • Basophils [ Time Frame: Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion ]
  • Absolute Neutrophils [ Time Frame: Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion ]
  • Absolute lymphocytes [ Time Frame: Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion ]
  • Absolute monocytes [ Time Frame: Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion ]
  • Absolute eosinophils [ Time Frame: Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion ]
  • Absolute basophils [ Time Frame: Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion ]
  • Immature Granulocytes [ Time Frame: Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion ]
  • Absolute Immature Granulocytes [ Time Frame: Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion ]
  • Platelets [ Time Frame: Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion ]
  • Prothrombin Time [ Time Frame: Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion ]
  • INR (international normalized ratio) [ Time Frame: Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion ]
  • Urine Pregnancy (if applicable) [ Time Frame: Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion ]

Central Contacts and Locations

Central contacts

Carmen Duron, RN, MHA, BSN

713-500-7395Maria.Carmen.Duron@uth.tmc.edu

Carla Mendoza, BSN, RN

713-500-8206Carla.D.Wilkerson@uth.tmc.edu

Locations

Memorial Hermann Hospital / UTHealth McGovern Medical School at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Carmen Duron, MHA, BSN, RN

713-500-7395Maria.Carmen.Duron@uth.tmc.edu

Carla Mendoza, BSN, RN

713-500-8206Carla.D.Wilkerson@uth.tmc.edu

Principal Investigator:

Charles S Cox, MD

The University of Texas Health Science at San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

John Moring, PhD

210-562-6716MoringJ@uthscsa.edu

Sarabeth Fox

210-415-4792foxs3@uthscsa.edu

Principal Investigator:

Peter T Fox, MD

More Information

Sponsor

Hope Biosciences LLC

Last update posted

Jul 15, 2026

Last verified

Jul, 2026

Keywords

  • severe
  • intracranial hemorrhage
  • chronic
  • neurological injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Hope Biosciences LLC on 2026-07-15.