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

January 6, 2014 updated by: Clinical Institute of the Brain, Russia

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Ekaterinburg, Russian Federation, 620026
        • Clinical Institute of the Brain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: G-CSF
Drug: Filgrastim
10 µg/kg subcutaneously once daily x 5 days
Other Names:
  • Leukostim

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dependence assessed by the modified Rankin scale
Time Frame: 180 day
180 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Impairment assessed by the Medical Research Consul scale and National Institutes of Health Stroke Scale
Time Frame: 180 day
180 day
Disability assessed by the Barthel Index and Glasgow Outcome Scale
Time Frame: 180 day
180 day
Infarct size assessed by the magneto-resonance imaging
Time Frame: 180 day
180 day
Safety was assessed as mortality, incidence of hemorrhagic transformation and serious adverse events
Time Frame: Duration of study
Duration of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinical Institute of the Brain, Russia

Collaborators

City Hospital No 40, Saint Petersburg, Russia
Institute of Medical Cells Technologies

Investigators

  • Principal Investigator: Andrey A Belkin, MD, PhD., Clinical Institute of the Brain, Russia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

May 12, 2009

First Submitted That Met QC Criteria

May 12, 2009

First Posted (Estimate)

May 13, 2009

Study Record Updates

Last Update Posted (Estimate)

January 7, 2014

Last Update Submitted That Met QC Criteria

January 6, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GKSF-8

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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