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NCT05951777 | RECRUITING | Traumatic Brain Injury

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

Hope Biosciences LLC

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.

Condition or disease

Traumatic Brain Injury

Intervention/treatment

Autologous HB-adMSCs

Normal Saline

Phase

PHASE2

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 51 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : Autologous Adipose-Derived Mesenchymal Stem Cells for Chronic Traumatic Brain Injury
Actual Study Start Date : 2024-04-16
Estimated Primary Completion Date : 2026-12
Estimated Study Completion Date : 2026-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 55 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Autologous Adipose-Derived Mesenchymal Stem Cells for Chronic Traumatic Brain Injury

Location Details

NCT05951777

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Texas

Memorial Hermann Hospital / UTHealth McGovern Medical School at Houston

Houston, Texas, United States, 77030

RECRUITING

United States, Texas

The University of Texas Health Science at San Antonio

Saint Anthony, Texas, United States, 78229