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RecruitingInterventionalPhase 2

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

NCT ID: NCT05951777Sponsor: Hope Biosciences LLCLast updated: 2025-09-29

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.

Detailed description

This study is a prospective, randomized, double-blind, placebo-controlled Phase 2a study of three infusions of autologous HB-adMSCs (Hope Biosciences adipose-derived mesenchymal stem cells) (2 x 10\^8 total cells per dose) administered over a 6 week period with 14 day intervals between infusions. Subjects will be monitored and assessed for infusion related toxicity for at least 1 hour after the infusion and by telephone 24hr. after each infusion. Safety assessments will be conducted at the study follow-up clinic visits 6 and 12 months, and 2 years (telephone call) after the last HB-adMSC (Hope Biosciences adipose-derived mesenchymal stem cells) infusion, or more frequently if infusion related adverse events are suspected.

Arms & interventions

  • BiologicalAutologous HB-adMSCs

    Hope Biosciences autologous adipose-derived mesenchymal stem cells

  • DrugNormal Saline

    Sterile Saline Solution 0.9%

Outcome measures

Primary

  • Glucose

    clinical lab evaluation of level of glucose in the blood (mg/dL)

    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

    clinical lab evaluation of level of calcium in the blood (mg/dL) clinical lab evaluation of level of calcium in the blood (mg/dL) clinical lab evaluation of level of calcium in the blood (mg/dL)

    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

    clinical lab evaluation of level of albumin in the blood (g/dL)

    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

    clinical lab evaluation of total protein in the blood (g/dL)

    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

    clinical lab evaluation of total sodium in the blood (mmol/L)

    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

    clinical lab evaluation of total carbon dioxide in the blood (mmol/L)

    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

    clinical lab evaluation of potassium in the blood (mmol/L)

    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

    clinical lab evaluation of chloride in the blood (mmol/L)

    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)

    clinical evaluation of blood urea nitrogen (BUN) (mg/dL)

    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

    clinical evaluation of creatinine in blood (mg/dL

    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

    clinical evaluation of alkaline phosphatase (ALP) in blood (IU/L)

    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

    clinical evaluation of alanine aminotransferase (ALT) in blood (IU/L)

    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

    clinical evaluation of aspartate aminotransferase (AST) in blood (IU/L)

    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

    clinical evaluation of total bilirubin in blood (mg/dL)

    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

    clinical evaluation of white blood cells (WBC) in blood (x 10\^3/uL)

    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

    clinical evaluation of red blood cells (RBC) in blood (x 10\^6/uL)

    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

    clinical evaluation of hemoglobin in blood (g/dL)

    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

    clinical evaluation of hematocrit in blood (%)

    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

    clinical evaluation of mean corpuscular volume (MCV) in blood (fL)

    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

    clinical evaluation of mean corpuscular hemoglobin (MCH) in blood (pg)

    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

    clinical evaluation of mean corpuscular hemoglobin concentration (MCHC) in blood (g/dL)

    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

    clinical evaluation of red cell distribution width (RDW) in blood (%)

    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

    clinical evaluation of neutrophils in blood (%)

    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

    clinical evaluation of lymphocytes in blood (%)

    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

    clinical evaluation of monocytes in blood (%)

    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

    clinical evaluation of eosinophils in blood (%)

    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

    clinical evaluation of basophils in blood (%)

    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

    clinical evaluation of absolute neutrophils in blood (x 10\^3/uL)

    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

    clinical evaluation of absolute lymphocytes in blood (x 10\^3/uL)

    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

    clinical evaluation of absolute monocytes in blood (x 10\^3/uL)

    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

    clinical evaluation of absolute eosinophils in blood (x 10\^3/uL)

    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

    clinical evaluation of absolute basophils in blood (x 10\^3/uL)

    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

    clinical evaluation of immature granulocytes in blood (%)

    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

    clinical evaluation of absolute immature granulocytes in blood (x 10\^3/uL)

    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

    clinical evaluation of platelets in blood (x 10\^3/uL)

    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

    clinical evaluation of time for blood to coagulate (seconds)

    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)

    clinical evaluation of international normalized ratio of blood coagulation (no unit)

    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)

    clinical evaluation of human chorionic gonadotropin (hCG) in urine (positive/negative)

    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

Secondary

  • Whole brain MRI (Magnetic resonance imaging)

    Time frame: Baseline, change from baseline at 6 months post-infusion

  • PET/DT-MRI (positron emission tomography/Diffusion tensor-Magnetic resonance imaging)

    Time frame: Baseline, change from baseline at 6 months post-infusion

  • Glasgow Outcome Scale - Extended

    Time frame: Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion

  • Disability Rating Scale

    Time frame: Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion

  • Behavior Rating of Executive Functions-Adult

    Time frame: Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion

  • TBI (Traumatic Brain Injury) Quality of Life Questionnaires

    Time frame: Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion

  • Brief Symptom Inventory 18

    Time frame: Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion

  • NIH Toolbox - Pattern Comparison Processing Speed Test

    Time frame: Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion

  • NIH Toolbox - Dimensional Change Card Sort Test

    Time frame: Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion

  • NIH Toolbox - Picture Vocabulary Test

    Time frame: Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion

  • NIH Toolbox - List Sorting Working Memory Test

    Time frame: Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion

  • NIH Toolbox - Flanker Inhibitory Control and Attention Test

    Time frame: Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion

  • NIH Toolbox - 9-hole Pegboard Dexterity Test

    Time frame: Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion

  • Rey Auditory Verbal Learning Test

    Time frame: Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion

  • Verbal Fluency

    Time frame: Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion

  • Wechsler Adult Intelligence Scale - IV: Processing Speed Index

    Time frame: Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion

  • Plasma cytokines

    Time frame: Baseline imaging (visit #2), change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion

  • Interleukin 1-alpha

    Time frame: Baseline imaging (visit #2), change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion

  • Interleukin 4

    Time frame: Baseline imaging (visit #2), change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion

  • Tumor necrosis factor alpha

    Time frame: Baseline imaging (visit #2), change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion

  • Interleukin 6

    Time frame: Baseline imaging (visit #2), change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion

  • Interleukin 10

    Time frame: Baseline imaging (visit #2), change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion

  • Albumin

    Time frame: Baseline imaging (visit #2), change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion

Eligibility criteria

Sex: AllAge: 18 Years to 55 YearsHealthy volunteers: No
Inclusion Criteria: 1. Adults between 18 and 55 years of age. 2. Documented functional neurological damage to the central nervous system from closed head trauma that is 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, 9. acute or chronic lung disease requiring significant medication/oxygen supplementation, 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, gene or cellular therapy. 2. Normal brain CT/MRI exam. 3. History of 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. 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.

Study locations (2)

Memorial Hermann Hospital / UTHealth McGovern Medical School at Houston

Houston, Texas, 77030

Recruiting
Carmen Duron, MHA, BSN, RN · Contact
713-500-7395Maria.Carmen.Duron@uth.tmc.edu
Carla Mendoza, BSN, RN · Contact
713-500-8206Carla.D.Wilkerson@uth.tmc.edu
Charles S Cox, MD · Principal Investigator

The University of Texas Health Science at San Antonio

San Antonio, Texas, 78229

Recruiting
John Moring, PhD · Contact
210-562-6716MoringJ@uthscsa.edu
Sarabeth Fox · Contact
210-415-4792foxs3@uthscsa.edu
Peter T Fox, MD · Principal Investigator
John C Moring, PhD · Sub Investigator