Autologous Adipose Derived Mesenchymal Stem Cells for Chronic Traumatic Brain Injury

Eligibility 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.
• 5. Ability to obtain consent from the subject or their legally authorized representative (LAR).
• 6. Ability to communicate in English or Spanish (required for validated neurocognitive outcome testing).
• 1. 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.
• 2. Normal brain CT/MRI (computed tomography/magnetic resonance imaging) exam.
• 3. 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.
• 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. Concurrent participation in interventional drug or device study.
• 8. 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.
• 9. Metal implants including baclofen pumps that would preclude DT-MRI (Diffusion tensor-magnetic resonance imaging).
• 10. Unwilling or unable to return for the follow-up study visits.