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Granulocyte-colony Stimulating Factor for Stem Cells Therapy for Acute Ischemic Stroke — STEMTHER  

Ischemic Stroke Clinical Trial

Official title:
Open Prospective Randomized Controlled Trial of Efficacy and Safety of Granulocyte-colony Stimulating Factor Leukostim for Acute Ischemic Stroke.

Clinical Trial Summary

The aim of the study is to investigate treatment with Leukostim (Filgrastim; granulocyte-colony stimulating factor; G-CSF) for acute ischemic stroke.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00901381
Study type Interventional
Source Clinical Institute of the Brain, Russia
Contact
Status Completed
Phase Phase 2
Start date June 2007
Completion date February 2009
View Details
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