A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy for the Treatment of Traumatic Brain Injury and Hypoxic-Ischemic Encephalopathy

NCT ID: NCT04063215

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2024-10-25

Brief Summary

This study aims to determine the safety of HB-adMSC infusion and treatment effects of HB-adMSC infusion on brain structure, neurocognitive/functional outcomes, and neuroinflammation after subacute and chronic neurological injury in adults.

Detailed Description

This study aims to determine the safety of HB-adMSC infusion and treatment effects of HB-adMSC infusion on global gray and/or white matter, as well as structural integrity of GM and WM regions of interest in the corpus callous and corticospinal tracts as measured by fractional anisotropy (FA) and mean diffusivity (MD) in specific regions known to correlate with specific neurocognitive deficits in patients after neurological injury.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HB-adMSC

HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)

Group Type: EXPERIMENTAL

HB-adMSCs

Intervention Type: BIOLOGICAL

Hope Biosciences autologous adipose-derived mesenchymal stem cells

Interventions

HB-adMSCs

Hope Biosciences autologous adipose-derived mesenchymal stem cells

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. adults between 18 and 55 years of age

2. documented head injury with functional neurological damage to the central nervous system 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

5. ability to obtain consent from the subject of their legally authorized representative (LAR)

6. ability to speak English or Spanish *required for validated neurocognitive outcome testing) -

Exclusion Criteria

1. known history of:

1. intellectual deficiency or psychiatric conditions likely to invalidate our ability to assess changes in cognition or behavior,

2. recently treated infection,

3. renal disease or altered renal function (screening serum creatinine > 1.5 mg/dL),

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. HIV+,

8. chemical or ETOH dependency that in the opinion of the investigator would preclude participation in the study,

9. acute or chronic lung disease requiring significant medication, oxygen supplementation, or mechanical ventilation,

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.

2. Normal brain CT/MRI exam

3. Spinal deformity, spinal surgery (including repeated epidural or spinal punctures), or spinal cord injury diagnosed by CT/MR or clinical exam

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 child bearing 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. participation in a concurrent interventional study

8. inability to undergo the diagnostic tests (PET/DT-MRI) or unwilling/unable to cooperate with the diagnostic tests and outcome assessments

9. unwilling or unable to return for 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-Clinical Research Unit (MMH-CRU)

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: English

View Document

Document Type: Informed Consent Form: Spanish

View Document

Other Identifiers

HBTBI01

Identifier Type: -

Identifier Source: org_study_id