Granulocyte-colony Stimulating Factor for Stem Cells Therapy for Acute Ischemic Stroke (STEMTHER)
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| ClinicalTrials.gov Identifier: NCT00901381 |
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Recruitment Status
:
Completed
First Posted
: May 13, 2009
Last Update Posted
: January 7, 2014
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Sponsor:
Clinical Institute of the Brain, Russia
Collaborators:
Institute of Medical Cells Technologies
City Hospital No 40, Saint Petersburg, Russia
Information provided by:
Clinical Institute of the Brain, Russia
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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 |
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 (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 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: G-CSF |
Drug: Filgrastim
10 µg/kg subcutaneously once daily x 5 days
Other Name: Leukostim
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| No Intervention: Control |
Primary Outcome Measures
:
- Dependence assessed by the modified Rankin scale [ Time Frame: 180 day ]
Secondary Outcome Measures
:
- Impairment assessed by the Medical Research Consul scale and National Institutes of Health Stroke Scale [ Time Frame: 180 day ]
- Disability assessed by the Barthel Index and Glasgow Outcome Scale [ Time Frame: 180 day ]
- Infarct size assessed by the magneto-resonance imaging [ Time Frame: 180 day ]
- Safety was assessed as mortality, incidence of hemorrhagic transformation and serious adverse events [ Time Frame: Duration of study ]
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| Ages Eligible for Study: | 40 Years to 70 Years (Adult, Senior) |
| 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
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
| 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 |
Additional Information:
| Responsible Party: | Andrey Belkin, Clinical Institute of the Brain, Russia |
| ClinicalTrials.gov Identifier: | NCT00901381 History of Changes |
| 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:
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Ischemic stroke Stem cells Colony-stimulating factors Filgrastim Randomized controlled trial |
Additional relevant MeSH terms:
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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 |