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

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ClinicalTrials.gov Identifier: NCT00901381
Recruitment Status : Completed
First Posted : May 13, 2009
Last Update Posted : January 7, 2014
Sponsor:
Collaborators:
Institute of Medical Cells Technologies
City Hospital No 40, Saint Petersburg, Russia
Information provided by:
Clinical Institute of the Brain, Russia

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

Condition or disease Intervention/treatment Phase
Ischemic Stroke Drug: Filgrastim Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Prospective Randomized Controlled Trial of Efficacy and Safety of Granulocyte-colony Stimulating Factor Leukostim for Acute Ischemic Stroke.
Study Start Date : June 2007
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: G-CSF Drug: Filgrastim
10 µg/kg subcutaneously once daily x 5 days
Other Name: Leukostim
No Intervention: Control


Outcome Measures
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Primary Outcome Measures :
  1. Dependence assessed by the modified Rankin scale [ Time Frame: 180 day ]

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

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00901381


Locations
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Russian Federation
Clinical Institute of the Brain
Ekaterinburg, Russian Federation, 620026
Sponsors and Collaborators
Clinical Institute of the Brain, Russia
Institute of Medical Cells Technologies
City Hospital No 40, Saint Petersburg, Russia
Investigators
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Principal Investigator: Andrey A Belkin, MD, PhD. Clinical Institute of the Brain, Russia
More Information
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Additional Information:
Publication with study results  This link exits the ClinicalTrials.gov site

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Responsible Party: Andrey Belkin, Clinical Institute of the Brain, Russia
ClinicalTrials.gov Identifier: NCT00901381    
Other Study ID Numbers: GKSF-8
First Posted: May 13, 2009    Key Record Dates
Last Update Posted: January 7, 2014
Last Verified: January 2014
Keywords provided by Clinical Institute of the Brain, Russia:
Ischemic stroke
Stem cells
Colony-stimulating factors
Filgrastim
Randomized controlled trial
Additional relevant MeSH terms:
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Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
 Pathologic Processes
Brain Infarction
Brain Ischemia
Lenograstim
Sargramostim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs