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

Clinical Institute of the Brain, Russia

Status and phase: Completed; Phase 2

Conditions: Ischemic Stroke

Treatments: Drug: Filgrastim

Study type: Interventional

Funder types: Other

Identifiers

NCT00901381

GKSF-8

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

G-CSF

Experimental group

Treatment:

Drug: Filgrastim

Control

No Intervention group