Ischemic StrokePhase 2STEMTHERNCT00901381
Granulocyte-colony Stimulating Factor for Stem Cells Therapy for Acute Ischemic Stroke
A Phase 2 study testing Filgrastim in people with Ischemic Stroke, run by Clinical Institute of the Brain, Russia at 1 site in Russia.
Trial summary
The aim of the study is to investigate treatment with Leukostim (Filgrastim; granulocyte-colony stimulating factor; G-CSF) for acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Filgrastim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteRussia
- Study dates
- Jun 2007to Feb 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Ischemic Stroke
- Being tested
- Filgrastim
- Keywords
- Ischemic stroke, Stem cells, Colony-stimulating factors, Filgrastim, Randomized controlled trial
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FilgrastimDrug
Also called Leukostim
10 µg/kg subcutaneously once daily x 5 days
| Study group | Role | What they receive |
|---|---|---|
| G-CSF | Experimental | Not described Receives: Drug: Filgrastim |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dependence assessed by the modified Rankin scale
Measured: 180 day
Secondary outcomes (4)
Impairment assessed by the Medical Research Consul scale and National Institutes of Health Stroke Scale
Measured: 180 day
Disability assessed by the Barthel Index and Glasgow Outcome Scale
Measured: 180 day
Infarct size assessed by the magneto-resonance imaging
Measured: 180 day
Safety was assessed as mortality, incidence of hemorrhagic transformation and serious adverse events
Measured: Duration of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2009 (estimated)
- Study startJun 2007
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Institute of the Brain, Russia
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Medical Cells Technologies, City Hospital No 40, Saint Petersburg, Russia
- Investigators
- Andrey A Belkin, MD, PhD., Principal investigator, Clinical Institute of the Brain, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901381
- Sponsor's protocol ID
- GKSF-8
- Acronym
- STEMTHER
- Status last verified
- Jan 2014
- First submitted
- 12 May 2009
- Last updated
- 7 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Prospective Randomized Controlled Trial of Efficacy and Safety of Granulocyte-colony Stimulating Factor Leukostim for Acute Ischemic Stroke.
- ClinicalTrials.gov ID
- NCT00901381
- Acronym / sponsor ID
- STEMTHER / GKSF-8
- Conditions
- Ischemic Stroke
- Keywords
- Ischemic stroke, Stem cells, Colony-stimulating factors, Filgrastim, Randomized controlled trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Clinical Institute of the Brain, RussiaUniversity, hospital or other
- Collaborators
- Institute of Medical Cells Technologies, City Hospital No 40, Saint Petersburg, Russia
- Study start
- Jun 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 13 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G-CSF | Experimental | Drug: Filgrastim |
| Control | No intervention | – |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FilgrastimAlso: Leukostim10 µg/kg subcutaneously once daily x 5 days | Drug | G-CSF |
Primary outcome
Dependence assessed by the modified Rankin scale
Time frame: 180 day
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2014.
- Publication with study resultsLink provided by the sponsor.
Related trials for Ischemic Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingPhase 3
Probucol for Symptomatic Intracranial and Extracranial Artery Stenosis
Ischemic Stroke, TIA
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrey A Belkin, MD, PhD. principal investigator
Clinical Institute of the Brain, Russia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Filgrastim in people with Ischemic Stroke, run by Clinical Institute of the Brain, Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dependence assessed by the modified Rankin scale (time frame: 180 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2014.