Autologous Adipose Derived Mesenchymal Stem Cells for Chronic Traumatic Brain Injury
Traumatic Brain Injury
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring severe, hypoxic-ischemic encephalopathy, intracranial hemorrhage, cerebral palsy, chronic, neurological injury
Eligibility Criteria
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. Ability to obtain consent from the subject or their legally authorized representative (LAR). Ability to communicate in English or Spanish (required for validated neurocognitive outcome testing). Exclusion Criteria: Known history of: a) intellectual deficiency or psychiatric conditions likely to invalidate our ability to assess changes in cognition or behavior; b) recently treated infection; c) renal disease or altered renal function (screening eGFR (estimated glomerular filtration rate) > 60 mL/min/1.73m2); d) hepatic disease or altered liver function (screening SGPT (serum glutamate pyruvate transaminase) > 150 U/L or T. Bilirubin >1.3 mg/dL); e) cancer; f) immunosuppression (screening WBC (white blood cell) < 3, 000 cells/ml); g) HIV+ (human immunodeficiency virus positive); h) chemical or ETOH (Ethanol/Alcohol) dependency that in the opinion of the investigator would preclude participation in the study; i) acute or chronic lung disease requiring significant medication/oxygen supplementation; j) bleeding disorders including immune-mediated heparin-induced thrombocytopenia; k) known sensitivity to heparin, Lovenox, and pork products; l) individuals with mechanical prosthetic heart valves; m) individuals who have received a stem cell treatment. Normal brain CT/MRI (computed tomography/magnetic resonance imaging) exam. Spinal deformity, spinal surgery (including repeated epidural or spinal punctures), or complete spinal cord injury diagnosed by CT (computed tomography) or MR (magnetic resonance) imaging or by clinical findings. 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 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. Concurrent participation in interventional drug or device study. Inability to undergo the diagnostic tests (PET/DT-MRI (positron emission tomography/diffusion tensor-magnetic resonance imaging)) or unwilling/unable to cooperate with the diagnostic tests and outcome assessments. Metal implants including baclofen pumps that would preclude DT-MRI (Diffusion tensor-magnetic resonance imaging). Unwilling or unable to return for the follow-up study visits.
Sites / Locations
- Memorial Hermann Hospital / UTHealth McGovern Medical School at Houston
- Audie Murphy VA Hospital, Bartter Research Unit
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Treatment
Placebo
Autologous Adipose Derived Mesenchymal Stem Cells
Normal Saline