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) (ESTABOMA)
Primary Purpose
Vascular Diseases, Cardiovascular Diseases, Acute Myocardial Infarction
Status
Unknown status
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Transplantation of BMMCs
Transplantation of CD 133+ cells
stenting of IRA
Sponsored by
About this trial
This is an interventional treatment trial for Vascular Diseases focused on measuring Bone marrow cells, Acute myocardial infarction, Transplantation of autologous mononuclear, Transplantation of autologous CD133 + cells
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Atrial fibrillation, a permanent form Valvular heart disease
- Severe comorbidity
Sites / Locations
- Scientific and Research Institution of Cardiology of Siberian Department of RAMS
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Transplantation of BMMCs
Transplantation of CD 133+ cells
stenting of IRA
Arm Description
Autologous BMCs aspiration and transplantation of these cells
Autologous CD 133+ BMCs aspiration and transplantation of CD 133+ cells
The only stenting of IRA
Outcomes
Primary Outcome Measures
Left ventricular ejection fraction (Echo)
Secondary Outcome Measures
incidence of cardiovascular death
incidence of the recurrent myocardial infarction
incidence of the angina
incidence of the heart failure
incidence of the stroke
incidence of the combined endpoint
incidence and severity of adverse events
Full Information
NCT ID
NCT01748383
First Posted
December 7, 2012
Last Updated
December 13, 2012
Sponsor
Russian Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01748383
Brief Title
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)
Acronym
ESTABOMA
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.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2005 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
September 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Russian Academy of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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, 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Diseases, Cardiovascular Diseases, Acute Myocardial Infarction
Keywords
Bone marrow cells, Acute myocardial infarction, Transplantation of autologous mononuclear, Transplantation of autologous CD133 + cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transplantation of BMMCs
Arm Type
Experimental
Arm Description
Autologous BMCs aspiration and transplantation of these cells
Arm Title
Transplantation of CD 133+ cells
Arm Type
Experimental
Arm Description
Autologous CD 133+ BMCs aspiration and transplantation of CD 133+ cells
Arm Title
stenting of IRA
Arm Type
Active Comparator
Arm Description
The only stenting of IRA
Intervention Type
Procedure
Intervention Name(s)
Transplantation of BMMCs
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Transplantation of CD 133+ cells
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
stenting of IRA
Intervention Description
The only stent implantation
Primary Outcome Measure Information:
Title
Left ventricular ejection fraction (Echo)
Time Frame
for an average of 7 years
Secondary Outcome Measure Information:
Title
incidence of cardiovascular death
Time Frame
7 years
Title
incidence of the recurrent myocardial infarction
Time Frame
7 years
Title
incidence of the angina
Time Frame
7 years
Title
incidence of the heart failure
Time Frame
7 years
Title
incidence of the stroke
Time Frame
7 years
Title
incidence of the combined endpoint
Time Frame
7 years
Title
incidence and severity of adverse events
Time Frame
7 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Atrial fibrillation, a permanent form Valvular heart disease
Severe comorbidity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vyacheslav Ryabov, MD, PhD
Organizational Affiliation
Scientific and Research Institution of Cardiology of Siberian Department of RAMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scientific and Research Institution of Cardiology of Siberian Department of RAMS
City
Tomsk
ZIP/Postal Code
634012
Country
Russian Federation
12. IPD Sharing Statement
Learn more about this trial
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)
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