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

Ischemic Stroke Clinical Trial

— STEMTHER  

Official title:

Open Prospective Randomized Controlled Trial of Efficacy and Safety of Granulocyte-colony Stimulating Factor Leukostim for Acute Ischemic Stroke.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00901381
• Other study ID #: GKSF-8
• Status: Completed
• Phase: Phase 2
• First received: May 12, 2009
• Last updated: January 6, 2014
• Start date: June 2007
• Est. completion date: February 2009

Study information

• Verified date: January 2014
• Source: Clinical Institute of the Brain, Russia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Filgrastim
10 µg/kg subcutaneously once daily x 5 days

Locations

Country	Name	City	State
Russian Federation	Clinical Institute of the Brain	Ekaterinburg

Sponsors (3)

Lead Sponsor	Collaborator
Clinical Institute of the Brain, Russia	City Hospital No 40, Saint Petersburg, Russia, Institute of Medical Cells Technologies

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	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

External Links

•   Publication with study results