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

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clinical Institute of the Brain, Russia
• Collaborators: City Hospital No 40, Saint Petersburg, Russia; Institute of Medical Cells Technologies
• Treatments: Lenograstim

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