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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)

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ClinicalTrials.gov Identifier: NCT01748383
Recruitment Status : Unknown
Verified December 2012 by Vyacheslav Ryabov, Russian Academy of Medical Sciences.
Recruitment status was:  Active, not recruiting
First Posted : December 12, 2012
Last Update Posted : December 17, 2012
Sponsor:
Information provided by (Responsible Party):
Vyacheslav Ryabov, Russian Academy of Medical Sciences

Tracking Information
First Submitted Date  ICMJE December 7, 2012
First Posted Date  ICMJE December 12, 2012
Last Update Posted Date December 17, 2012
Study Start Date  ICMJE September 2005
Estimated Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2012)
Left ventricular ejection fraction (Echo) [ Time Frame: for an average of 7 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2012)
  • 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 faulure [ 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Vascular Diseases
  • Cardiovascular Diseases
  • Acute Myocardial Infarction
Intervention  ICMJE
  • Procedure: Transplantation of BMMCs
    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.
  • Procedure: Transplantation of CD 133+ cells
    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.
  • Procedure: stenting of IRA
    The only stent implantation
Study Arms  ICMJE
  • Experimental: Transplantation of BMMCs
    Autologous BMCs aspiration and transplantation of these cells
    Intervention: Procedure: Transplantation of BMMCs
  • Experimental: Transplantation of CD 133+ cells
    Autologous CD 133+ BMCs aspiration and transplantation of CD 133+ cells
    Intervention: Procedure: Transplantation of CD 133+ cells
  • Active Comparator: stenting of IRA
    The only stenting of IRA
    Intervention: Procedure: stenting of IRA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 11, 2012)
85
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2014
Estimated Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01748383
Other Study ID Numbers  ICMJE 99
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vyacheslav Ryabov, Russian Academy of Medical Sciences
Study Sponsor  ICMJE Russian Academy of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Vyacheslav Ryabov, MD, PhD Scientific and Research Institution of Cardiology of Siberian Department of RAMS
PRS Account Russian Academy of Medical Sciences
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP