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 Clinical Hospital #40
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

May 12, 2009
January 6, 2014
June 2007
February 2009   (final data collection date for primary outcome measure)
Dependence assessed by the modified Rankin scale [ Time Frame: 180 day ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00901381 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Granulocyte-colony Stimulating Factor for Stem Cells Therapy for Acute Ischemic Stroke
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Ischemic Stroke
Drug: Filgrastim
10 µg/kg subcutaneously once daily x 5 days
Other Name: Leukostim
  • Experimental: G-CSF
    Intervention: Drug: Filgrastim
  • No Intervention: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
February 2009
February 2009   (final data collection date for primary outcome measure)

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
Both
40 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT00901381
GKSF-8
Yes
Andrey Belkin, Clinical Institute of the Brain, Russia
Clinical Institute of the Brain, Russia
  • Institute of Medical Cells Technologies
  • City Clinical Hospital #40
Principal Investigator: Andrey A Belkin, MD, PhD. Clinical Institute of the Brain, Russia
Clinical Institute of the Brain, Russia
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP