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

Prior treatment

• Concurrent participation in interventional drug or device study.
• Metal implants including baclofen pumps that would preclude DT-MRI.

Other illness

• 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.
• Uncorrectable vision impairment that will prevent completion of neurocognitive tests require visual processing.

Lab values

• 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/participation in the study,
  • acute or chronic lung disease requiring significant medication/oxygen supplementation,
  • bleeding disorders, thrombocytopenia, 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.

Other

• Normal brain CT/MRI exam.
• Planned epidural or spinal anesthesia, or undergoing spinal puncture, complete spinal cord injury.
• 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 during the study.
• Inability to undergo the diagnostic tests (PET/DT-MRI) or unwilling/unable to cooperate with the diagnostic tests and outcome assessments.
• Unwilling or unable to return for the follow-up study visits.

• Adults between 18 and 55 years of age.
• Documented functional neurological damage to the central nervous system from blunt force head trauma 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).