title: Granulocyte-colony stimulating factor (G-CSF) in stroke patients with concomitant vascular disease--a randomized controlled trial.
abstract: BACKGROUND
  G-CSF has been shown in animal models of stroke to promote functional and structural regeneration of the central nervous system. It thus might present a therapy to promote recovery in the chronic stage after stroke.
  
  
  METHODS
  Here, we assessed the safety and tolerability of G-CSF in chronic stroke patients with concomitant vascular disease, and explored efficacy data. 41 patients were studied in a double-blind, randomized approach to either receive 10 days of G-CSF (10 µg/kg body weight/day), or placebo. Main inclusion criteria were an ischemic infarct >4 months prior to inclusion, and white matter hyperintensities on MRI. Primary endpoint was number of adverse events. We also explored changes in hand motor function for activities of daily living, motor and verbal learning, and finger tapping speed, over the course of the study.
  
  
  RESULTS
  Adverse events (AEs) were more frequent in the G-CSF group, but were generally graded mild or moderate and from the known side-effect spectrum of G-CSF. Leukocyte count rose after day 2 of G-CSF dosing, reached a maximum on day 8 (mean 42/nl), and returned to baseline 1 week after treatment cessation. No significant effect of treatment was detected for the primary efficacy endpoint, the test of hand motor function.
  
  
  CONCLUSIONS
  These results demonstrate the feasibility, safety and reasonable tolerability of subcutaneous G-CSF in chronic stroke patients. This study thus provides the basis to explore the efficacy of G-CSF in improving chronic stroke-related deficits.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00298597.
authors.affiliation: Department of Neurology, Charité-Universitätsmedizin Berlin, Berlin, Germany. agnes.floeel@charite.de
authors.forename: Agnes
authors.initials: A
authors.lastname: Floel
authors.forename: Tobias
authors.initials: T
authors.lastname: Warnecke
authors.forename: Thomas
authors.initials: T
authors.lastname: Duning
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Lating
authors.forename: Jan
authors.initials: J
authors.lastname: Uhlenbrock
authors.forename: Armin
authors.initials: A
authors.lastname: Schneider
authors.forename: Gerhard
authors.initials: G
authors.lastname: Vogt
authors.forename: Rico
authors.initials: R
authors.lastname: Laage
authors.forename: Winfried
authors.initials: W
authors.lastname: Koch
authors.forename: Stefan
authors.initials: S
authors.lastname: Knecht
authors.forename: Wolf-Rüdiger
authors.initials: WR
authors.lastname: Schäbitz
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D003071:Cognition / Q000187:drug effects; D015331:Cohort Studies; D004311:Double-Blind Method; D005240:Feasibility Studies; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009043:Motor Activity / Q000187:drug effects; D020521:Stroke / Q000150:complications / Q000188:drug therapy*; D014652:Vascular Diseases / Q000188:drug therapy* / Q000209:etiology
chemical_list: D016179:Granulocyte Colony-Stimulating Factor