Autologous Adipose-Derived Mesenchymal Stem Cells for Chronic Traumatic Brain Injury
Purpose
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
- Traumatic Brain Injury
Eligibility
- Eligible Ages
- Between 18 Years and 55 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- Known history of: 1. intellectual deficiency or psychiatric conditions likely to invalidate our ability to assess changes in cognition or behavior, psychiatric conditions prior to TBI, 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 Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Treatment |
Autologous Adipose Derived Mesenchymal Stem Cells |
|
|
Placebo Comparator Placebo |
Normal Saline |
|
Recruiting Locations
Houston, Texas 77030
More Details
- Status
- Recruiting
- Sponsor
- Hope Biosciences
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.