Pediatric Autologous Bone Marrow Mononuclear Cells for Severe Traumatic Brain Injury

Exclusion Criteria

• •1. Known history of: a. previous brain injury, b. intellectual deficiency or psychiatric condition, defined as inability to independently function in a regular classroom that may invalidate our ability to assess post-injury changes in cognition or behavior (ADHD and/or other learning disabilities are NOT an exclusion), c. neurologic impairment and/or deficit, d. seizure disorder requiring anti-convulsant therapy, e. recently treated infection, f. renal disease or altered renal function (post-resuscitation serum creatinine \> 1.5 mg/dL), g. hepatic disease or altered liver function (post-resuscitation, non-contusion related SGPT \> 150 μ/L and/or T. Bilirubin \>1.3 mg/dL), h. cancer, i. immunosuppression as defined by WBC \< 3, 000 cells/ml at admission, j. HIV+, k. chemical or ETOH dependency, l. history of child abuse, m. premature birth (\<37 weeks GA/2500 grams) resulting in cognitive/physical disabilities and/or developmental delay.
• •2. Obliteration of perimesencephalic cistern on initial head CT/MRI suggesting prolonged hypoxic ischemic insult/herniation syndrome.
• •3. Initial hospital ICP \> 40 mm Hg.
• •4. Hemodynamic instability at the time of screening defined as SBP \<90 mmHg, ongoing fluid resuscitation and/or requirement for inotropic support to maintain MAP at or above normal for age - does not include CPP based inotropic support. IVF alone does not exclude from enrollment.
• •5. Uncorrected coagulopathy at the time of bone marrow harvest defined as INR \> 1.6, PTT \> 38 sec; PLT\< 100,000; Fibrinogen \< 100 g/dL.
• •6. Unstable pelvic fractures defined as requiring early operative fixation.
• •7. Pulmonary contusions defined as a chest x-ray with non-anatomic opacification and/or PaO2:FiO2 ratio \< 250 associated with the mechanism of injury.
• •8. Greater than AAST Grade 3 solid or hollow visceral injury of the abdomen and/or pelvis as diagnosed by CT or other imaging.
• •9. Spinal cord injury diagnosed by CT/MR imaging or 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.
• •15. Penetrating brain injury.