scholarly journals Clinical study of low-dose granulocyte-colony stimulating factor in acute ischemic stroke

Nosotchu ◽  
2014 ◽  
Vol 36 (2) ◽  
pp. 125-128
Author(s):  
Shunya Takizawa
Keyword(s):  
Ischemic Stroke ◽  
Clinical Study ◽  
Acute Ischemic Stroke ◽  
Low Dose ◽  
Granulocyte Colony Stimulating Factor ◽  
Colony Stimulating Factor ◽  
Stimulating Factor

Endogenous granulocyte colony-stimulating factor: a biomarker in acute ischemic stroke

Biomarkers ◽  
2012 ◽  
Vol 17 (4) ◽  
pp. 319-324 ◽  
Author(s):  
Shih-Chieh Yu ◽  
Chen-Ling Kuo ◽  
Ching-Shan Huang ◽  
Cheng-Shu Chang ◽  
Shey-Lin Wu ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Granulocyte Colony Stimulating Factor ◽  
Colony Stimulating Factor ◽  
Stimulating Factor

Granulocyte-colony-stimulating Factor for Acute Ischemic Stroke: A Randomized Controlled Trial (STEMTHER)

2011 ◽  
Vol 2 (3) ◽  
pp. 358-365 ◽  
Author(s):  
Andrey Marisovich Alasheev ◽  
Andrey Avgustovich Belkin ◽  
Ilya Naumovich Leiderman ◽  
Roman Alekseyevich Ivanov ◽  
Tatyana Mikhailovna Isakova
Keyword(s):  
Randomized Controlled Trial ◽  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Controlled Trial ◽  
Granulocyte Colony Stimulating Factor ◽  
Colony Stimulating Factor ◽  
Randomized Controlled ◽  
Stimulating Factor

scholarly journals Granulocyte Colony–Stimulating Factor in Patients With Acute Ischemic Stroke

Stroke ◽  
2013 ◽  
Vol 44 (10) ◽  
pp. 2681-2687 ◽  
Author(s):  
E. Bernd Ringelstein ◽  
Vincent Thijs ◽  
Bo Norrving ◽  
Angel Chamorro ◽  
Franz Aichner ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Scale Score ◽  
Diffusion Weighted Imaging ◽  
National Institutes Of Health ◽  
Drug Candidate ◽  
Granulocyte Colony Stimulating Factor ◽  
Colony Stimulating Factor ◽  
End Points ◽  
Stimulating Factor

Background and Purpose— Granulocyte colony–stimulating factor (G-CSF; AX200; Filgrastim) is a stroke drug candidate with excellent preclinical evidence for efficacy. A previous phase IIa dose–escalation study suggested potential efficacy in humans. The present large phase IIb trial was powered to detect clinical efficacy in acute ischemic stroke patients. Methods— G-CSF (135 µg/kg body weight intravenous over 72 hours) was tested against placebo in 328 patients in a multinational, multicenter, randomized, and placebo-controlled trial (NCT00927836; www.clinicaltrial.gov ). Main inclusion criteria were ≤9-hour time window after stroke onset, infarct localization in the middle cerebral artery territory, baseline National Institutes of Health Stroke Scale score range of 6 to 22, and baseline diffusion-weighted imaging lesion size ≥15 mL. Primary and secondary end points were the modified Rankin scale score and the National Institutes of Health Stroke Scale score at day 90, respectively. Data were analyzed using a prespecified model that adjusted for age, National Institutes of Health Stroke Scale score at baseline, and initial infarct volume (diffusion-weighted imaging). Results— G-CSF treatment failed to meet the primary and secondary end points of the trial. For additional end points such as mortality, Barthel index, or infarct size at day 30, G-CSF did not show efficacy either. There was, however, a trend for reduced infarct growth in the G-CSF group. G-CSF showed the expected peripheral pharmacokinetic and pharmacodynamic profiles, with a strong increase in leukocytes and monocytes. In parallel, the cytokine profile showed a significant decrease of interleukin-1. Conclusions— G-CSF, a novel and promising drug candidate with a comprehensive preclinical and clinical package, did not provide any significant benefit with respect to either clinical outcome or imaging biomarkers. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00927836.

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