Trial | NCT00901381  Report issue

Title

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.

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    20
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 Started
Jun 30
2007
Primary Completion
Feb 28
2009
Study Completion
Feb 28
2009
Last Update
Jan 07
2014
Estimate

Drug Filgrastim

10 µg/kg subcutaneously once daily x 5 days

  • Other names: Leukostim

G-CSF Experimental

Control No Intervention

Criteria 

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
No Results Posted