Overview
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.
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.
Eligibility
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
- History of spinal cord injury.
- Diagnosed with a genetic or metabolic disorder related to the neurologic condition.
- Other acute or chronic medical conditions that, in the opinion of the investigator, may increase the risks associated with study participation.
- 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.
- Concurrent participation in interventional drug or device study.
- Inability to undergo the diagnostic tests (PET/DT-MRI) or unwilling/unable to cooperate with the diagnostic tests and outcome assessments.
- Metal implants including baclofen pumps that would preclude DT-MRI.
- Unwilling or unable to return for the follow-up study visits.