Ischemic Stroke
Conditions
Keywords
Ischemic stroke, Stem cells, Colony-stimulating factors, Filgrastim, Randomized controlled trial
Brief 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.
Interventions
DRUGFilgrastim
10 µg/kg subcutaneously once daily x 5 days
Sponsors
Institute of Medical Cells Technologies
City Hospital No 40, Saint Petersburg, Russia
Clinical Institute of the Brain, Russia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dependence assessed by the modified Rankin scale | 180 day |
Secondary
| Measure | 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 |
Countries
Russia
Outcome results
None listed