title: Neuroprotective therapy using granulocyte colony-stimulating factor for patients with worsening symptoms of compression myelopathy, Part 1: a phase I and IIa clinical trial.
abstract: OBJECTIVE
  Based on the neuroprotective effects of granulocyte colony-stimulating factor (G-CSF) on experimental spinal cord injury, we initiated a clinical trial that evaluated the safety and efficacy of neuroprotective therapy using G-CSF for patients with worsening symptoms of compression myelopathy.
  
  
  METHODS
  We obtained informed consent from 15 patients, in whom the Japanese Orthopaedic Association (JOA) score for cervical myelopathy decreased two points or more during a recent 1-month period. G-CSF (5 or 10 μg/kg/day) was intravenously administered for five consecutive days. We evaluated motor and sensory functions of the patients and the presence of adverse events related to G-CSF therapy.
  
  
  RESULTS
  G-CSF administration suppressed the progression of myelopathy in all 15 patients. Neurological improvements in motor and sensory functions were obtained in all patients after the administration, although the degree of improvement differed among the patients. Nine patients in the 10-μg group (n=10) underwent surgical treatment at 1 month or later after G-CSF administration. In the 10-μg group, the mean JOA recovery rates 1 and 6 months after administration were 49.9±15.1 and 59.1±16.3%, respectively. On the day following the start of G-CSF therapy, the white blood cell count increased to more than 22,700 cells/mm3. It varied from 12,000 to 50,000 and returned to preadministration levels 3 days after completing G-CSF treatment. No serious adverse events occurred during or after treatment.
  
  
  CONCLUSIONS
  The results indicate that G-CSF administration at 10 μg/kg/day is safe for patients with worsening symptoms of compression myelopathy and may be effective for their neurological improvement.
authors.affiliation: Spine Section, Department of Orthopaedic Surgery, Chiba University Graduate School of Medicine, 1-8-1 Inohana, Chuo-ku, Chiba, 260-8677, Japan.
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Sakuma
authors.forename: Masashi
authors.initials: M
authors.lastname: Yamazaki
authors.forename: Akihiko
authors.initials: A
authors.lastname: Okawa
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Takahashi
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: Ryo
authors.initials: R
authors.lastname: Kadota
authors.forename: Masayuki
authors.initials: M
authors.lastname: Hashimoto
authors.forename: Kazuhisa
authors.initials: K
authors.lastname: Takahashi
authors.forename: Masao
authors.initials: M
authors.lastname: Koda
mesh_terms: D000328:Adult; D000368:Aged; D018450:Disease Progression; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage*; D006801:Humans; D007275:Injections, Intravenous / Q000379:methods; D008297:Male; D008875:Middle Aged; D018696:Neuroprotective Agents / Q000008:administration & dosage*; D010292:Paresthesia / Q000188:drug therapy / Q000209:etiology / Q000503:physiopathology; D011782:Quadriplegia / Q000188:drug therapy / Q000209:etiology / Q000503:physiopathology; D020127:Recovery of Function / Q000187:drug effects / Q000502:physiology; D013116:Spinal Cord / Q000187:drug effects* / Q000502:physiology; D013117:Spinal Cord Compression / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology*; D055009:Spondylosis / Q000150:complications / Q000503:physiopathology*; D016896:Treatment Outcome
chemical_list: D018696:Neuroprotective Agents; D016179:Granulocyte Colony-Stimulating Factor