title: Neuroprotective therapy with granulocyte colony-stimulating factor in acute spinal cord injury: a comparison with high-dose methylprednisolone as a historical control.
abstract: OBJECTIVE
  We performed a phase I/IIa clinical trial and confirmed the safety and feasibility of granulocyte colony-stimulating factor (G-CSF) as neuroprotective therapy in patients with acute spinal cord injury (SCI). In this study, we retrospectively analyzed the clinical outcome in SCI patients treated with G-CSF and compared these results to a historical cohort of SCI patients treated with high-dose methylprednisolone sodium succinate (MPSS).
  
  
  METHODS
  In the G-CSF group (n = 28), patients were treated from August 2009 to July 2012 within 48 h of the injury, and G-CSF (10 μg/kg/day) was administered intravenously for five consecutive days. In the MPSS group (n = 34), patients underwent high-dose MPSS therapy from August 2003 to July 2005 following the NASCIS II protocol. We evaluated the ASIA motor score and the AIS grade elevation between the time of treatment and 3-month follow-up and adverse events.
  
  
  RESULTS
  The ΔASIA motor score was significantly higher in the G-CSF group than in the MPSS group (p < 0.01). When we compared AIS grade elevation in patients with AIS grades B/C incomplete paralysis, 17.9% of patients in the G-CSF group had an AIS grade elevation of two steps compared to 0% of patients in the MPSS group (p < 0.05), and the incidence of pneumonia was significantly higher in the MPSS group (42.9%) compared to the G-CSF group (8.3%) (p < 0.05).
  
  
  CONCLUSIONS
  These results suggest that G-CSF administration is safe and effective, but a prospective randomized controlled clinical trial is needed to compare the efficacy of MPSS versus G-CSF treatment in patients with SCI.
authors: Department of Orthopedic Surgery, Chiba University Graduate School of Medicine, 1-8-1 Inohana, Chuo-Ku, Chiba, 2608670, Japan.
authors: Koshiro
authors: K
authors: Kamiya
authors: Masao
authors: M
authors: Koda
authors: Takeo
authors: T
authors: Furuya
authors: Kei
authors: K
authors: Kato
authors: Hiroshi
authors: H
authors: Takahashi
authors: Tsuyoshi
authors: T
authors: Sakuma
authors: Taigo
authors: T
authors: Inada
authors: Mitsutoshi
authors: M
authors: Ota
authors: Satoshi
authors: S
authors: Maki
authors: Akihiko
authors: A
authors: Okawa
authors: Yasuo
authors: Y
authors: Ito
authors: Kazuhisa
authors: K
authors: Takahashi
authors: Masashi
authors: M
authors: Yamazaki
mesh_terms: D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008776:Methylprednisolone Hemisuccinate / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D018696:Neuroprotective Agents / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D020127:Recovery of Function / Q000187:drug effects; D012189:Retrospective Studies; D013119:Spinal Cord Injuries / Q000188:drug therapy* / Q000503:physiopathology; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018696:Neuroprotective Agents; D016179:Granulocyte Colony-Stimulating Factor; D008776:Methylprednisolone Hemisuccinate