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

This study has been completed.
Sponsor:
Collaborators:
Institute of Medical Cells Technologies
City Hospital No 40, Saint Petersburg, Russia
Information provided by:
Clinical Institute of the Brain, Russia
ClinicalTrials.gov Identifier:
NCT00901381
First received: May 12, 2009
Last updated: January 6, 2014
Last verified: January 2014
History of Changes
  Purpose
The aim of the study is to investigate treatment with Leukostim (Filgrastim; granulocyte-colony stimulating factor; G-CSF) for acute ischemic stroke.

Condition Intervention Phase
Ischemic Stroke
 Drug: Filgrastim
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Clinical Institute of the Brain, Russia:

Primary Outcome Measures:
  • Dependence assessed by the modified Rankin scale [ Time Frame: 180 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Impairment assessed by the Medical Research Consul scale and National Institutes of Health Stroke Scale [ Time Frame: 180 day ] [ Designated as safety issue: No ]
  • Disability assessed by the Barthel Index and Glasgow Outcome Scale [ Time Frame: 180 day ] [ Designated as safety issue: No ]
  • Infarct size assessed by the magneto-resonance imaging [ Time Frame: 180 day ] [ Designated as safety issue: No ]
  • Safety was assessed as mortality, incidence of hemorrhagic transformation and serious adverse events [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
Enrollment: 20
Study Start Date: June 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: G-CSF Drug: Filgrastim
10 µg/kg subcutaneously once daily x 5 days
Other Name: Leukostim
No Intervention: Control

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.
  Eligibility
Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00901381

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

Additional Information:
Publication with study results  This link exits the ClinicalTrials.gov site

Responsible Party: Andrey Belkin, Clinical Institute of the Brain, Russia
ClinicalTrials.gov Identifier: NCT00901381     History of Changes
Other Study ID Numbers: GKSF-8 
Study First Received: May 12, 2009
Last Updated: January 6, 2014
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by Clinical Institute of the Brain, Russia:
Ischemic stroke
Stem cells
Colony-stimulating factors
Filgrastim
Randomized controlled trial

Additional relevant MeSH terms:
Stroke
Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
 Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 23, 2016