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

Clinical Institute of the Brain, Russia20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ischemic Stroke

Interventions

FilgrastimDRUG

10 µg/kg subcutaneously once daily x 5 days

Eligibility

Sex: ALLMin age: 40 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Clinical Institute of the Brain

Yekaterinburg, Russia

Outcomes

Primary Outcomes

Dependence assessed by the modified Rankin scale

Time frame: 180 day

Secondary Outcomes

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

Data from ClinicalTrials.gov

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