Pediatric Autologous Bone Marrow Mononuclear Cells for Severe Traumatic Brain Injury

Study Design: Multicenter, randomized, blinded, placebo controlled, Bayesian adaptive dose escalation design. Study Intervention: Single dose administered within 48 hours from time of injury. Controls will undergo a sham harvest and receive similarly labeled/external appearance and volume of 0.9% NaCl. BMMNC's will be harvested and undergo processing under cGMP conditions to obtain 6x10\^6 cells/kg or 10x10\^6 cells/kg weight. The cellular product/placebo will be infused within 48 hours of injury. Safety Monitoring \& Follow-Up: Subjects will be monitored for infusion related toxicity post-infusion through hospital discharge and follow-up return study visits. Laboratory and imaging studies will be repeated at the 1, 6, and 12-month follow-up visits. A medical safety monitor (MSM) will review blinded SAE reports following post-infusion Day 14 for each subject in real time to ensure good clinical practice and to quickly identify safety concerns. The MSM will remain blinded to the treatment assignment, unless the NINDS appointed DSMB approves unblinding.