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

NCT05951777 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: HBTBI02
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

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

Keywords

severe; intracranial hemorrhage; chronic; neurological injury

Outcome Measures

Primary Outcomes (38)

• Glucose

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

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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 (%)

  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)

  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)

  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)

  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 (%)

  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 (%)

  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 (%)

  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 (%)

  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 (%)

  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 (%)

  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)

  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)

  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)

  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)

  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)

  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 (%)

  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)

  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)

  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)

  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)

  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)

  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 Outcomes (23)

• Whole brain MRI (Magnetic resonance imaging)

  Baseline, change from baseline at 6 months post-infusion

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

  Baseline, change from baseline at 6 months post-infusion

• Glasgow Outcome Scale - Extended

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

• Disability Rating Scale

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

• Behavior Rating of Executive Functions-Adult

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

Study Arms (2)

Treatment

EXPERIMENTAL

Autologous Adipose Derived Mesenchymal Stem Cells

Biological: Autologous HB-adMSCs

Placebo

PLACEBO COMPARATOR

Normal Saline

Drug: Normal Saline

Interventions

Autologous HB-adMSCs BIOLOGICAL

Hope Biosciences autologous adipose-derived mesenchymal stem cells

Treatment

Normal Saline DRUG

Sterile Saline Solution 0.9%

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults between 18 and 55 years of age.
• Documented functional neurological damage to the central nervous system from closed head trauma that is unlikely to improve with present standard of care approaches.
• A Glasgow Outcome Scale-Extended (GOS-E) score \>2 and ≤6.
• Onset or diagnosis of the injury or disease process greater than 6 months and \<= 20 years.
• Ability to obtain consent from the subject or their legally authorized representative (LAR).
• Ability to verbally communicate in English or Spanish (required for validated neurocognitive outcome testing).

You may not qualify if:

• Known history of:
• 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,
• recently treated infection,
• renal disease or altered renal function (screening eGFR \< 60 mL/min/1.73m2),
• hepatic disease or altered liver function (screening SGPT \> 150 U/L or T. Bilirubin \>1.3 mg/dL),
• cancer,
• immunosuppression (screening WBC \< 3, 000 cells/ml),
• Positive infectious disease tests including HIV, Hep. B, Hep. C., and Syphilis,
• chemical or ETOH dependency that in the opinion of the investigator would preclude enrollment,
• acute or chronic lung disease requiring significant medication/oxygen supplementation,
• bleeding disorders including immune-mediated heparin-induced thrombocytopenia,
• known sensitivity to heparin, Lovenox, and pork products,
• individuals with mechanical prosthetic heart valves,
• individuals who have received a stem cell treatment, gene or cellular therapy.
• Normal brain CT/MRI exam.

Sponsors & Collaborators

• Hope Biosciences LLC: lead
• The University of Texas Health Science Center, Houston: collaborator

Study Sites (2)

Memorial Hermann Hospital / UTHealth McGovern Medical School at Houston

Houston, Texas, 77030, United States

RECRUITING

The University of Texas Health Science at San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Lymphoma, Follicular; Intracranial Hemorrhages; Bronchiolitis Obliterans Syndrome; Trauma, Nervous System

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Wounds and Injuries; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Charles S Cox, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carmen Duron, RN, MHA, BSN

CONTACT

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

Carla Mendoza, BSN, RN

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 19, 2023
• Study Start: April 16, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

US (2)