A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy for the Treatment of Traumatic Brain Injury and Hypoxic-Ischemic Encephalopathy

Prior treatment

• Spinal deformity, spinal surgery (including repeated epidural or spinal punctures), or spinal cord injury diagnosed by CT/MR or clinical exam
• participation in a concurrent interventional study

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

Lab values

• known history of:
  • intellectual deficiency or psychiatric conditions likely to invalidate our ability to assess changes in cognition or behavior,
  • recently treated infection,
  • renal disease or altered renal function (screening serum creatinine \> 1.5 mg/dL),
  • 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),
  • HIV+,
  • chemical or ETOH dependency that in the opinion of the investigator would preclude participation in the study,
  • acute or chronic lung disease requiring significant medication, oxygen supplementation, or mechanical ventilation,
  • 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.

Other

• Normal brain CT/MRI exam
• 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
• 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 follow-up study visits -

• adults between 18 and 55 years of age
• documented head injury with functional neurological damage to the central nervous system 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 of their legally authorized representative (LAR)
• ability to speak English or Spanish \*required for validated neurocognitive outcome testing) -