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

Completed

Phase 2 Results N/A

Trial Description

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

Interventions

  • Filgrastim Drug
    Other Names: Leukostim
    Intervention Desc: 10 µg/kg subcutaneously once daily x 5 days
    ARM 1: Kind: Experimental
    Label: G-CSF

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Dependence assessed by the modified Rankin scale 180 day No
Secondary Impairment assessed by the Medical Research Consul scale and National Institutes of Health Stroke Scale 180 day No
Secondary Disability assessed by the Barthel Index and Glasgow Outcome Scale 180 day No
Secondary Infarct size assessed by the magneto-resonance imaging 180 day No
Secondary Safety was assessed as mortality, incidence of hemorrhagic transformation and serious adverse events Duration of study Yes

Sponsors