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

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

Detailed Description
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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.

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

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Drug: Filgrastim


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 40 to 70 years old CT/MRI confirmed ischemic stroke in carotid area during 48 hours after the onset of clinical signs Level of conscious lower than 15 and higher than 8 points by the Glasgow Coma Scale Acute extremity paresis lower than 4 points by Medical Research Consul scale Exclusion Criteria: Premorbid dependency (modified Rankin Scale > 0) Intracerebral hemorrhage Transitory ischemic attack Patients with previous stroke Any disorders, that can affect interpretation of results (e.g. psychiatric or movement disorders) Hematological diseases Coagulopathy Malignancy Pregnancy and lactation Organ dysfunction that would preclude tests required for this study Known allergic reaction to G-CSF or a component of G-CSF Patients that have received a cytokine within the last 1 month or are currently receiving a cytokine treatment

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: G-CSF<br> | Drug: Filgrastim<br>* 10 µg/kg subcutaneously once daily x 5 days<br>* Other names: Leukostim;|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dependence assessed by the modified Rankin scale |  | 180 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impairment assessed by the Medical Research Consul scale and National Institutes of Health Stroke Scale |  | 180 day | 
| Disability assessed by the Barthel Index and Glasgow Outcome Scale |  | 180 day | 
| Infarct size assessed by the magneto-resonance imaging |  | 180 day | 
| Safety was assessed as mortality, incidence of hemorrhagic transformation and serious adverse events |  | Duration of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischemic stroke, Stem cells, Colony-stimulating factors, Filgrastim, Randomized controlled trial