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

Primary Purpose

Ischemic Stroke

Status
Completed
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Filgrastim
Sponsored by
Clinical Institute of the Brain, Russia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring Ischemic stroke, Stem cells, Colony-stimulating factors, Filgrastim, Randomized controlled trial

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Institute of the Brain

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

G-CSF

Control

Arm Description

Outcomes

Primary Outcome Measures

Dependence assessed by the modified Rankin scale

Secondary Outcome Measures

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

Full Information

First Posted
May 12, 2009
Last Updated
January 6, 2014
Sponsor
Clinical Institute of the Brain, Russia
Collaborators
Institute of Medical Cells Technologies, City Hospital No 40, Saint Petersburg, Russia
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1. Study Identification

Unique Protocol Identification Number
NCT00901381
Brief Title
Granulocyte-colony Stimulating Factor for Stem Cells Therapy for Acute Ischemic Stroke
Acronym
STEMTHER
Official Title
Open Prospective Randomized Controlled Trial of Efficacy and Safety of Granulocyte-colony Stimulating Factor Leukostim for Acute Ischemic Stroke.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
Ischemic stroke, Stem cells, Colony-stimulating factors, Filgrastim, Randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
G-CSF
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Filgrastim
Other Intervention Name(s)
Leukostim
Intervention Description
10 µg/kg subcutaneously once daily x 5 days
Primary Outcome Measure Information:
Title
Dependence assessed by the modified Rankin scale
Time Frame
180 day
Secondary Outcome Measure Information:
Title
Impairment assessed by the Medical Research Consul scale and National Institutes of Health Stroke Scale
Time Frame
180 day
Title
Disability assessed by the Barthel Index and Glasgow Outcome Scale
Time Frame
180 day
Title
Infarct size assessed by the magneto-resonance imaging
Time Frame
180 day
Title
Safety was assessed as mortality, incidence of hemorrhagic transformation and serious adverse events
Time Frame
Duration of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrey A Belkin, MD, PhD.
Organizational Affiliation
Clinical Institute of the Brain, Russia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Institute of the Brain
City
Ekaterinburg
ZIP/Postal Code
620026
Country
Russian Federation

12. IPD Sharing Statement

Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/24323654
Description
Publication with study results

Learn more about this trial

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

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