A Phase 2 interventional study of Filgrastim in Ischemic Stroke, sponsored by Clinical Institute of the Brain, Russia. Completed at 1 site in Russian Federation. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-01-07.
Sponsored by Clinical Institute of the Brain, Russia · Phase 2, Interventional, and Treatment
The aim of the study is to investigate treatment with Leukostim (Filgrastim; granulocyte-colony stimulating factor; G-CSF) for acute ischemic stroke.
Stroke is one of the main reasons of mortality and morbidity all over the world. In economically developed countries stroke takes 2 or 3 place in the structure of morbidity and mortality. In animal models, it was shown that autological stem cells transplantation significantly increased perfusion of ischemic area and improved lost motor and sensor functions. Granulocyte-colony stimulating factor (G-CSF) was used in some clinical trials without following autological transplantation. However, there are no enough evidence-based proved results of G-GSF safety and effectiveness in acute ischemic stroke. In order to determine safety and efficiency of G-CSF administration together with conventional treatment and conventional intensive care protocol during acute ischemic stroke we organized this clinical trial.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 20 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Clinical Institute of the Brain, Russia is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Filgrastim
10 µg/kg subcutaneously once daily x 5 days
Also known as: Leukostim
Dependence assessed by the modified Rankin scale
Time frame: 180 day
Impairment assessed by the Medical Research Consul scale and National Institutes of Health Stroke Scale
Time frame: 180 day
Disability assessed by the Barthel Index and Glasgow Outcome Scale
Time frame: 180 day
Infarct size assessed by the magneto-resonance imaging
Time frame: 180 day
Safety was assessed as mortality, incidence of hemorrhagic transformation and serious adverse events
Time frame: Duration of study
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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Clinical Institute of the Brain, Russia