title: Multicenter prospective nonrandomized controlled clinical trial to prove neurotherapeutic effects of granulocyte colony-stimulating factor for acute spinal cord injury: analyses of follow-up cases after at least 1 year.
abstract: METHODS
  An open-labeled multicenter prospective nonrandomized controlled clinical trial.
  
  
  OBJECTIVE
  To confirm the feasibility of using granulocyte colony-stimulating factor (G-CSF) for treatment of acute spinal cord injury (SCI).
  
  
  BACKGROUND
  We previously reported that G-CSF promotes functional recovery after compression-induced SCI in mice. On the basis of these findings, we conducted a multicenter prospective controlled clinical trial to assess the feasibility of G-CSF therapy for patients with acute SCI.
  
  
  METHODS
  The trial ran from August 2009 to March 2011, and included 41 patients with SCI treated within 48 hours of onset. Informed consent was obtained from all patients. After providing consent, patients were divided into 2 groups. In the G-CSF group (17 patients), G-CSF (10 μg/kg/d) was intravenously administered for 5 consecutive days, and in the control group (24 patients), patients were similarly treated except for the G-CSF administration. We evaluated motor and sensory functions using the American Spinal Cord Injury Association score and American Spinal Cord Injury Association impairment scale at 1 week, 3 months, 6 months, and 1 year after onset.
  
  
  RESULTS
  Only 2 patients did not experience American Spinal Cord Injury Association impairment scale improvement in the G-CSF group. In contrast, 15 patients in the control group did not experience American Spinal Cord Injury Association impairment scale improvement. In the analysis of increased American Spinal Cord Injury Association motor score, a significant increase in G-CSF group was detected from 1 week after the administration compared with the control group. After that, some spontaneous increase of motor score was detected in control group, but the significant increase in G-CSF group was maintained until 1 year of follow-up.
  
  
  CONCLUSIONS
  Despite the limitation that patient selection was not randomized, the present results suggest the possibility that G-CSF administration has beneficial effects on neurological recovery in patients with acute SCI.
  
  
  METHODS
  3.
authors.affiliation: *Spine Section, Department of Orthopaedic Surgery, Chiba University Graduate School of Medicine, Chiba, Japan; †Spinal Cord Injury Center, Hokkaido Chuo Rosai Hospital, Hokkaido, Japan; ‡Department of Orthopaedic Surgery, Kobe Red Cross Hospital, Kobe, Japan; §Department of Orthopaedic Surgery, Japan LHWO Spinal Injuries Center, Iizuka, Japan; and ¶Department of Clinical Research, Chiba University Hospital, Chiba, Japan.
authors.forename: Taigo
authors.initials: T
authors.lastname: Inada
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Takahashi
authors.forename: Masashi
authors.initials: M
authors.lastname: Yamazaki
authors.forename: Akihiko
authors.initials: A
authors.lastname: Okawa
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Sakuma
authors.forename: Kei
authors.initials: K
authors.lastname: Kato
authors.forename: Mitsuhiro
authors.initials: M
authors.lastname: Hashimoto
authors.forename: Koichi
authors.initials: K
authors.lastname: Hayashi
authors.forename: Takeo
authors.initials: T
authors.lastname: Furuya
authors.forename: Takayuki
authors.initials: T
authors.lastname: Fujiyoshi
authors.forename: Junko
authors.initials: J
authors.lastname: Kawabe
authors.forename: Chikato
authors.initials: C
authors.lastname: Mannoji
authors.forename: Tomohiro
authors.initials: T
authors.lastname: Miyashita
authors.forename: Ryo
authors.initials: R
authors.lastname: Kadota
authors.forename: Yukio
authors.initials: Y
authors.lastname: Someya
authors.forename: Osamu
authors.initials: O
authors.lastname: Ikeda
authors.forename: Masayuki
authors.initials: M
authors.lastname: Hashimoto
authors.forename: Kota
authors.initials: K
authors.lastname: Suda
authors.forename: Tomomichi
authors.initials: T
authors.lastname: Kajino
authors.forename: Haruki
authors.initials: H
authors.lastname: Ueda
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Ito
authors.forename: Takayoshi
authors.initials: T
authors.lastname: Ueta
authors.forename: Hideki
authors.initials: H
authors.lastname: Hanaoka
authors.forename: Kazuhisa
authors.initials: K
authors.lastname: Takahashi
authors.forename: Masao
authors.initials: M
authors.lastname: Koda
mesh_terms: D000208:Acute Disease; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D020127:Recovery of Function / Q000187:drug effects* / Q000502:physiology*; D013119:Spinal Cord Injuries / Q000175:diagnosis* / Q000188:drug therapy* / Q000503:physiopathology; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D016179:Granulocyte Colony-Stimulating Factor