A Multicenter Trial of Autologous Bone Marrow Mononuclear Cells for the Treatment of Adult Severe Traumatic Brain Injury

Date de début de l'étude : 21 novembre 2016

Inclusion Criteria: 1. Adults 18 to 55 years of age on the day of injury, 2. Non-penetrating closed head trauma. 3. Glasgow Coma Score between (GCS) between 3 and 8, (best un-medicated post-resuscitation score during screening). 4. Ability to obtain legally authorized representative consent for participation and complete the BMMNC/Sham harvest and cell/placebo infusion within 48 hours of the initial injury. 5. Ability to speak English or Spanish. Exclusion Criteria: 1. Known history of: 1. previous brain injury, 2. intellectual deficiency or psychiatric condition likely to invalidate our ability to assess post-injury changes in cognition or behavior, 3. neurologic impairment and/or deficit, 4. seizure disorder requiring anti-convulsant therapy, 5. recently treated significant infection, 6. renal disease/altered renal function (post-resuscitation serum creatinine \> 1.5 mg/dL), 7. chronic hepatic disease or altered liver function (post-resuscitation SGPT \> 150 U/L, and/or T. Bilirubin \>1.3 mg/dL), 8. cancer, 9. Chemical or ETOH dependency, 10. immunosuppression (admission WBC \< 3X103), 11. HIV positive status; 2. Obliteration of perimesencephalic cistern on initial head CT/MRI suggesting prolonged hypoxic ischemic insult; 3. Initial hospital ICP \> 40 mm Hg; 4. Hemodynamic instability at the time of screening defined as SBP \< 90mmHg, ongoing fluid resuscitation and/or requirement for inotropic support to maintain MAP at or above normals for age - does not include CPP based inotropic support; 5. Uncorrectable coagulopathy at the time of screening; 6. Unstable pelvic fractures that in the P.I.'s opinion would preclude the bone marrow / sham harvest; 7. Pulmonary contusions defined as a chest x-ray with non-anatomic opacification and PaO2:FiO2 ratio \< 250 associated with the mechanism of injury; 8. Greater than AAST Grade III solid or hollow visceral injury of the abdomen and/or pelvis diagnosed by CT or other imaging; 9. Spinal cord injury diagnosed by CT or MR imaging or by clinical findings; 10. Persistent hypoxia defined as SaO2 \< 94% for \> 30 minutes occurring at any time from hospital admission to time of consent; 11. Positive pregnancy test (if applicable); 12. Concurrent participation in an interventional drug/device research study; 13. Unwillingness to return for follow-up visits; 14. Contraindications to MRI.