期刊
NEUROSURGERY
卷 68, 期 3, 页码 588-600出版社
OXFORD UNIV PRESS INC
DOI: 10.1227/NEU.0b013e318207734c
关键词
Cellular therapy; Clinical trial; Mononuclear cell; Pediatric; Stem cell; Traumatic brain injury
资金
- Children's Memorial Hermann Foundation, Brown Foundation, Inc., National Institute of Health [R21 HD042659-01A1, UL1 RR024148, 1T32 GM 087-92-01, R01 NS052505]
- National Heart, Lung, and Blood Institute [NO1-HB-37163]
- CBR, Inc.
- Athersys, Inc.
- KCI, Inc.
BACKGROUND: Severe traumatic brain injury (TBI) in children is associated with substantial long-term morbidity and mortality. Currently, there are no successful neuroprotective/neuroreparative treatments for TBI. Numerous preclinical studies suggest that bone marrow-derived mononuclear cells (BMMNCs), their derivative cells (marrow stromal cells), or similar cells (umbilical cord blood cells) offer neuroprotection. OBJECTIVE: To determine whether autologous BMMNCs are a safe treatment for severe TBI in children. METHODS: Ten children aged 5 to 14 years with a postresuscitation Glasgow Coma Scale of 5 to 8 were treated with 6 3 106 autologous BMMNCs/ kg body weight delivered intravenously within 48 hours after TBI. To determine the safety of the procedure, systemic and cerebral hemodynamics were monitored during bone marrow harvest; infusion-related toxicity was determined by pediatric logistic organ dysfunction (PELOD) scores, hepatic enzymes, Murray lung injury scores, and renal function. Conventional magnetic resonance imaging (cMRI) data were obtained at 1 and 6 months postinjury, as were neuropsychological and functional outcome measures. RESULTS: All patients survived. There were no episodes of harvest-related depression of systemic or cerebral hemodynamics. There was no detectable infusion-related toxicity as determined by PELOD score, hepatic enzymes, Murray lung injury scores, or renal function. cMRI imaging comparing gray matter, white matter, and CSF volumes showed no reduction from 1 to 6 months postinjury. Dichotomized Glasgow Outcome Score at 6 months showed 70% with good outcomes and 30% with moderate to severe disability. CONCLUSION: Bone marrow harvest and intravenous mononuclear cell infusion as treatment for severe TBI in children is logistically feasible and safe.
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