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Phase 2 Pediatric Autologous BMMNC for Severe TBI



Eligibility Criteria:

INCLUSION:

  • Between 5 and 15 years of age on the day of injury
  • Hospital admission Glasgow Coma Score between 3 and 8
  • Initial injury occurring less than 24 hours prior to consent

EXCLUSION:

  • Known history of:  previous brain injury, psychiatric disorder, neurologic impairment and/or deficit, seizure disorder requiring anti-convulsant therapy, recently treated infection, renal disease or altered renal function, hepatic disease or altered liver function, cancer, immunosuppression, HIV positive, chemical and/or alcohol (ETOH) dependency, history of child abuse, or premature birth.
  • Initial hospital intracranial pressure (ICP)>40 mm/Hg
  • Hemodynamic instability at the time of consent (24 hours post-injury)
  • Uncorrected coagulopathy at the time of bone marrow harvest
  • Unstable pelvic fractures
  • Pulmonary contusions
  • Greater than American Association for the Surgery of Trauma (AAST) Grade 3 solid or hollow visceral injury of the abdomen and/or pelvis as diagnosed by CT or other imaging
  • Spinal cord injury diagnosed by CT or MRI or by clinical findings
  • Persistent hypoxia defined as SaO2<94% for > 30 minutes occurring at any time from hospital admission to time of consent
  • Participation in a concurrent interventional study
  • Contraindications to MRI
  • Penetrating brain injury

Last updated July 22, 2014