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

NCT ID: NCT05951777

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-16
• Study Completion Date: 2026-12-31

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.

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.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment

Autologous Adipose Derived Mesenchymal Stem Cells

Group Type: EXPERIMENTAL

Autologous HB-adMSCs

Intervention Type: BIOLOGICAL

Hope Biosciences autologous adipose-derived mesenchymal stem cells

Placebo

Normal Saline

Group Type: PLACEBO_COMPARATOR

Normal Saline

Intervention Type: DRUG

Sterile Saline Solution 0.9%

Interventions

Autologous HB-adMSCs

Hope Biosciences autologous adipose-derived mesenchymal stem cells

Intervention Type: BIOLOGICAL

Normal Saline

Sterile Saline Solution 0.9%

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: collaborator

Hope Biosciences LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles S Cox, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

Memorial Hermann Hospital / UTHealth McGovern Medical School at Houston

Houston, Texas, United States

Site Status: RECRUITING

The University of Texas Health Science at San Antonio

San Antonio, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Carmen Duron, RN, MHA, BSN

Role: CONTACT

Maria.Carmen.Duron@uth.tmc.edu

713-500-7395

Carla Mendoza, BSN, RN

Role: CONTACT

Carla.D.Wilkerson@uth.tmc.edu

713-500-8206

Facility Contacts

Carmen Duron, MHA, BSN, RN

Role: primary

Maria.Carmen.Duron@uth.tmc.edu

713-500-7395

Carla Mendoza, BSN, RN

Role: backup

Carla.D.Wilkerson@uth.tmc.edu

713-500-8206

John Moring, PhD

Role: primary

MoringJ@uthscsa.edu

210-562-6716

Sarabeth Fox

Role: backup

foxs3@uthscsa.edu

210-415-4792

Other Identifiers

HBTBI02

Identifier Type: -

Identifier Source: org_study_id