Vascular DiseasesPhase 2ESTABOMANCT01748383
The Long-term and Short-term Efficacy and Safety of Transplantation Autologous Bone Marrow Cells (BMCs) in Patients With the First STEMI (ST Segment Elevation Myocardial Infarction)
A Phase 2 study testing Transplantation of BMMCs, Transplantation of CD 133+ cells and stenting of IRA in people with Vascular Diseases and Cardiovascular Diseases, run by Russian Academy of Medical Sciences at 1 site in Russia.
Trial summary
The purpose of this study is to test the hypothesis that the intracoronary transplantation of autologous mononuclear and CD 133 + bone marrow cells will improve left ventricular contractile function and will reduce the combined end points after the primary STEMI (mortality, recurrent myocardial infarction, angina… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Vascular Diseases, Cardiovascular Diseases, Acute Myocardial Infarction
- What is being tested?
- Transplantation of BMMCs, Transplantation of CD 133+ cells and stenting of IRA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteRussia
- Study dates
- Sep 2005to Sep 2014
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and to 75 Years
- Informed consent
- First STEMI
- Term admission to an intensive care unit in the first 24 hours of onset
- Time reperfusion of the IRA is not earlier than 4 hours after the initial onset of acute transmural myocardial infarction
Who cannot join
- Atrial fibrillation, a permanent form Valvular heart disease
- Severe comorbidity
Trial locations and contacts
1 site in 1 country.
Russia1 site
Scientific and Research Institution of Cardiology of Siberian Department of RAMS
Tomsk, 634012
About this study
Official title: Autologous Mononuclear and Cluster of Differentiation 133+ (CD 133+) Bone Marrow Cells, Growth Factors and Cytokines in the Remodeling of the Heart in Patients During and in the Late Periods After STEMI.
The purpose of this study is to test the hypothesis that the intracoronary transplantation of autologous mononuclear and CD 133 + bone marrow cells will improve left ventricular contractile function and will reduce the combined end points after the primary STEMI (mortality, recurrent myocardial infarction, angina, heart failure, stroke).
Read the detailed description
The study was randomized, opened, controlled. 85 patients with the first STEMI were enrolled. Patients were divided to three groups. On admission all patients were received thrombolytic therapy by 1,5 million U streptokinase. Transplantation of autologous mononuclear bone marrow cells (BMMCs) and аutologous CD133 + cells by balloon catheter placed into infarct-related artery (IRA) was performed at once after stent implantation in 28 patients patients (1st group) and in 10 patients (2nd group) on the 7-21 days of STEMI. Another 47 patients (3nd group) undergo only stent implantation into IRA the same day of STEMI.
Autologous BMMCs were obtained from bone marrow aspirate by gradient centrifugation. Echocardiography, Holter monitoring were performed. Plasma concentration of the pro-inflammatory and anti-inflammatory cytokines (IL1, 6,8,10), of the growth factors (stem cell factor - SCF, vascular endothelial growth factor - VEGF, hepatocyte growth factor - HGF, fibroblast growth factor - FGF, insulin-like growth factor - IGF), the number of circulating CD34 +38-, CD133 +, СD117 +, CD90 +34- stem cells were determined in these patients in the acute and sub-acute myocardial infarction period.
It is going 7 years after the beginning of planned to evaluate left ventricular function of these patients, incidence of cardiovascular end points (death, recurrent myocardial infarction, angina, heart failure, stroke) and their combinations, to evaluate the safety of transplantation of autologous BMCs (formation of intra-myocardial tumor or neoplastic processes of other sites) after 7 years from the beginning of study.
- Being tested
- Transplantation of BMMCs, Transplantation of CD 133+ cells, stenting of IRA
- Keywords
- Bone marrow cells, Acute myocardial infarction, Transplantation of autologous mononuclear, Transplantation of autologous CD133 + cells
- Medical subject headings
- Vascular Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transplantation of BMMCsProcedure or surgery
The wing of the ilium was punctured under the local anesthesia for receiving of autologous BMCs. 100 ml of bone marrow aspirate was taken. BMMCs were obtained by the method of the gradient centrifugation. Autologous BMMCs in the number 93±43 million transplantation by balloon catheter performed into IRA at once after stent implantation.
Transplantation of CD 133+ cellsProcedure or surgery
The wing of the ilium was punctured under the local anesthesia for receiving of autologous BMCs. 100 ml of bone marrow aspirate was taken. Autologous CD133 + cells were obtained by the method of the magnetic separation. Phenotyping of the transplanted cells was performed by the cytofluorimetry. Autologous CD 133+ BMCs in the number 5,7 (0,45;9,0) million transplantation by balloon catheter performed into IRA at once after stent implantation.
stenting of IRAProcedure or surgery
The only stent implantation
| Study group | Role | What they receive |
|---|---|---|
| Transplantation of BMMCs | Experimental | Autologous BMCs aspiration and transplantation of these cells Receives: Procedure: Transplantation of BMMCs |
| Transplantation of CD 133+ cells | Experimental | Autologous CD 133+ BMCs aspiration and transplantation of CD 133+ cells Receives: Procedure: Transplantation of CD 133+ cells |
| stenting of IRA | Active comparator | The only stenting of IRA Receives: Procedure: stenting of IRA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular ejection fraction (Echo)
Measured: for an average of 7 years
Secondary outcomes (7)
incidence of cardiovascular death
Measured: 7 years
incidence of the recurrent myocardial infarction
Measured: 7 years
incidence of the angina
Measured: 7 years
incidence of the heart failure
Measured: 7 years
incidence of the stroke
Measured: 7 years
incidence of the combined endpoint
Measured: 7 years
incidence and severity of adverse events
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startSep 2005
- Primary completionSep 2013 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseasesStudies 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
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Russian Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vyacheslav Ryabov, Russian Academy of Medical Sciences
- Investigators
- Vyacheslav Ryabov, MD, PhD, Principal investigator, Scientific and Research Institution of Cardiology of Siberian Department of RAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748383
- Sponsor's protocol ID
- 99
- Acronym
- ESTABOMA
- Status last verified
- Dec 2012
- First submitted
- 7 Dec 2012
- Last updated
- 17 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Mononuclear and Cluster of Differentiation 133+ (CD 133+) Bone Marrow Cells, Growth Factors and Cytokines in the Remodeling of the Heart in Patients During and in the Late Periods After STEMI.
- ClinicalTrials.gov ID
- NCT01748383
- Acronym / sponsor ID
- ESTABOMA / 99
- Keywords
- Bone marrow cells, Acute myocardial infarction, Transplantation of autologous mononuclear, Transplantation of autologous CD133 + cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Russian Academy of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 12 Dec 2012 (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 purpose of this study is to test the hypothesis that the intracoronary transplantation of autologous mononuclear and CD 133 + bone marrow cells will improve left ventricular contractile function and will reduce the combined end points after the primary STEMI (mortality, recurrent myocardial infarction, angina, heart failure, stroke).
Detailed description
The study was randomized, opened, controlled. 85 patients with the first STEMI were enrolled. Patients were divided to three groups. On admission all patients were received thrombolytic therapy by 1,5 million U streptokinase. Transplantation of autologous mononuclear bone marrow cells (BMMCs) and аutologous CD133 + cells by balloon catheter placed into infarct-related artery (IRA) was performed at once after stent implantation in 28 patients patients (1st group) and in 10 patients (2nd group) on the 7-21 days of STEMI. Another 47 patients (3nd group) undergo only stent implantation into IRA the same day of STEMI.
Autologous BMMCs were obtained from bone marrow aspirate by gradient centrifugation. Echocardiography, Holter monitoring were performed. Plasma concentration of the pro-inflammatory and anti-inflammatory cytokines (IL1, 6,8,10), of the growth factors (stem cell factor - SCF, vascular endothelial growth factor - VEGF, hepatocyte growth factor - HGF, fibroblast growth factor - FGF, insulin-like growth factor - IGF), the number of circulating CD34 +38-, CD133 +, СD117 +, CD90 +34- stem cells were determined in these patients in the acute and sub-acute myocardial infarction period.
It is going 7 years after the beginning of planned to evaluate left ventricular function of these patients, incidence of cardiovascular end points (death, recurrent myocardial infarction, angina, heart failure, stroke) and their combinations, to evaluate the safety of transplantation of autologous BMCs (formation of intra-myocardial tumor or neoplastic processes of other sites) after 7 years from the beginning of study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transplantation of BMMCs | Experimental | Procedure: Transplantation of BMMCsAutologous BMCs aspiration and transplantation of these cells |
| Transplantation of CD 133+ cells | Experimental | Procedure: Transplantation of CD 133+ cellsAutologous CD 133+ BMCs aspiration and transplantation of CD 133+ cells |
| stenting of IRA | Active comparator | Procedure: stenting of IRAThe only stenting of IRA |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years and to 75 Years
- Informed consent
- First STEMI
- Term admission to an intensive care unit in the first 24 hours of onset
- Time reperfusion of the IRA is not earlier than 4 hours after the initial onset of acute transmural myocardial infarction
Key exclusion criteria (2 listed)
- Atrial fibrillation, a permanent form Valvular heart disease
- Severe comorbidity
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 |
|---|---|---|
| Transplantation of BMMCsThe wing of the ilium was punctured under the local anesthesia for receiving of autologous BMCs. 100 ml of bone marrow aspirate was taken. BMMCs were obtained by the method of the gradient centrifugation. Autologous BMMCs in the number 93±43 million transplantation by balloon catheter performed into IRA at once after stent implantation. | Procedure or surgery | Transplantation of BMMCs |
| Transplantation of CD 133+ cellsThe wing of the ilium was punctured under the local anesthesia for receiving of autologous BMCs. 100 ml of bone marrow aspirate was taken. Autologous CD133 + cells were obtained by the method of the magnetic separation. Phenotyping of the transplanted cells was performed by the cytofluorimetry. Autologous CD 133+ BMCs in the number 5,7 (0,45;9,0) million transplantation by balloon catheter performed into IRA at once after stent implantation. | Procedure or surgery | Transplantation of CD 133+ cells |
| stenting of IRAThe only stent implantation | Procedure or surgery | stenting of IRA |
Primary outcome
Left ventricular ejection fraction (Echo)
Time frame: for an average of 7 years
7 secondary outcomes
incidence of cardiovascular death
Time frame: 7 years
incidence of the recurrent myocardial infarction
Time frame: 7 years
incidence of the angina
Time frame: 7 years
incidence of the heart failure
Time frame: 7 years
incidence of the stroke
Time frame: 7 years
incidence of the combined endpoint
Time frame: 7 years
incidence and severity of adverse events
Time frame: 7 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2012.
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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.
Vyacheslav Ryabov, MD, PhD principal investigator
Scientific and Research Institution of Cardiology of Siberian Department of RAMS
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 Transplantation of BMMCs, Transplantation of CD 133+ cells and stenting of IRA in people with Vascular Diseases and Cardiovascular Diseases, run by Russian Academy of Medical Sciences 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 17 Dec 2012. 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?
Results are not available in the source record.
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?
Left ventricular ejection fraction (Echo) (time frame: for an average of 7 years). 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 17 Dec 2012.