Status:
COMPLETED
Granulocyte-colony Stimulating Factor for Stem Cells Therapy for Acute Ischemic Stroke
Lead Sponsor:
Clinical Institute of the Brain, Russia
Collaborating Sponsors:
Institute of Medical Cells Technologies
City Hospital No 40, Saint Petersburg, Russia
Conditions:
Ischemic Stroke
Eligibility:
All Genders
40-70 years
Phase:
PHASE2
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 mo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00901381
Start Date
June 1 2007
End Date
February 1 2009
Last Update
January 7 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical Institute of the Brain
Yekaterinburg, Russia, 620026