NCT00901381

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Clinical Institute of the Brain, Russia · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Filgrastim	10 µg/kg subcutaneously once daily x 5 days

Timeline

• Start date: 2007-06-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2009-05-13
• Last updated: 2014-01-07

Locations

1 site across 1 country: Russia