Journal Article The Chiba Medical Society Award (2015):Granulocyte colony-stimulating factor-mediated neuroprotective therapy for acute spinal cord injury: From bench to bedside

KODA, Masao  ,  国府田, 正雄  ,  FURUYA, Takeo  ,  古谷, 丈雄  ,  INADA, Taigo  ,  稲田, 大悟  ,  KAMIYA, Koshiro  ,  神谷, 光史郎  ,  OTA, Mitsutoshi  ,  大田, 光俊  ,  MAKI, Satoshi  ,  牧, 聡  ,  IJIMA, Yasushi  ,  飯島, 靖  ,  SAITO, Junya  ,  斉藤, 淳哉  ,  TAKAHASHI, Kazuhisa  ,  高橋, 和久  ,  YAMAZAKI, Masashi  ,  山崎, 正志

91 ( 6 )  , pp.e33 - e37 , 2015-12-01 , 千葉医学会 , チバ イガクカイ , The Chiba Medical Society
To elucidate neuroprotective effect of granulocyte colony-stimulating factor (G-CSF) for acute spinal cord injury (SCI), we performed experimental studies and early phase of clinical trials. The results of experimental studies showed that G-CSF exerts neuroprotective effects for acute SCI via mobilization of bone marrow-derived cells into injured spinal cord, suppression of neuronal apoptosis, suppression of inflammatory cytokine up-regulation, suppression of oligodendrocyte apoptosis and promotion of angiogenesis. Next we moved to clinical trial. In a phase I/IIa trial, no adverse events were observed. Then, we conducted a non-randomized, non-blinded, comparative trial, which suggested the efficacy of G-CSF for promoting neurological recovery. We are now preparing a phase III trial to confirm G-CSF treatment efficacy for acute SCI. The current trial will include cervical SCI within 48 hours after injury. Patients will be randomly assigned to G-CSF and placebo groups and evaluated by double blinded manner. Our primary endpoint is changes in American Spinal Injury Association motor scores from baseline to 3 months. Each group will include 44 patients (88 total patients). After completion of this clinical trial, pharmaceutical approval will be applied for health insurance publication. G-CSF-mediated neuroprotection is a promising candidate for a novel therapeutic approach for SCI.

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