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Trial record 1 of 1 for:    NCT01753440
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Allogeneic Stem Cells Implantation Combined With Coronary Bypass Grafting in Patients With Ischemic Cardiomyopathy

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ClinicalTrials.gov Identifier: NCT01753440
Recruitment Status : Completed
First Posted : December 20, 2012
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Kyriakos Anastasiadis, AHEPA University Hospital

Tracking Information
First Submitted Date  ICMJE December 18, 2012
First Posted Date  ICMJE December 20, 2012
Last Update Posted Date May 7, 2019
Actual Study Start Date  ICMJE November 2012
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2019)
  • iMP-related adverse events [ Time Frame: 12 months ]
    Major adverse cardiac and cerebrovascular events including death, postoperative myocardial infarction, need for revascularization, stroke, hospitalization for worsening heart failure, myocardial rupture, infectious myocarditis, or sustained ventricular arrhythmias.
  • Hypersensitivity [ Time Frame: 12 months ]
    Hypersensitivity reaction (fever, urticaria, hemolytic anemia, hypotension, immune thrombocytopenia)
Original Primary Outcome Measures  ICMJE
 (submitted: December 19, 2012)
  • Left ventricular ejection fraction [ Time Frame: one year ]
    Change in left ventricular ejection fraction assesed with echocardiography after intramyocardial implantation of allogeneic mesenchymal stem cells.
  • Myocardial segmental perfusion [ Time Frame: one year ]
    change in segmental perfusion as assesed with SPECT after intramyocardial implantation of allogeneic mesenchymal stem cells.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2019)
  • Scar reduction [ Time Frame: 4 months ]
    Myocardial scar size reduction assessed with SPECT
  • Scar reduction [ Time Frame: 12 months ]
    Myocardial scar size reduction assess with SPECT
  • LVEF [ Time Frame: 12 months ]
    Left ventricular ejection fraction
  • Change in quality of life [ Time Frame: 12 months ]
    Quality of life evaluated with MLHFQ
Original Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2012)
  • all-cause mortality [ Time Frame: one year ]
  • all-cause morbidity [ Time Frame: one year ]
  • major adverse cardiac and cerebrovascular events [ Time Frame: one year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Allogeneic Stem Cells Implantation Combined With Coronary Bypass Grafting in Patients With Ischemic Cardiomyopathy
Official Title  ICMJE Study on the Safety and Efficacy of Allogeneic Mesenchymal Stem Cell Implantation Combined With Bypass Grafting in Patients With Coronary Artery Disease and Ischemic Cardiomyopathy.
Brief Summary The aim of the present study is to investigate safety and efficacy of intramyocardial implantation of a novel mesenchymal precursor cell type (iMP) in patients with ischemic cardiomyopathy at the time of coronary artery bypass grafting.
Detailed Description This study aims to investigates in situ cardiac regeneration utilizing precision delivery of a novel mesenchymal precursor cell type (iMP) during coronary artery bypass surgery (CABG) in patients with ischemic cardiomyopathy (LVEF < 40 %). Preoperative scintigraphy imaging (SPECT) will be used to identify hibernating myocardium not suitable for conventional myocardial revascularization for iMP implantation. iMP cells will be implanted intramyocardially in predefined viable peri-infarct areas that show poor perfusion, which could not be grafted due to poor target vessel quality. Postoperatively, SPECT will be used to identify changes in scar area.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Coronary Artery Disease
  • Ischemic Cardiomyopathy
Intervention  ICMJE Procedure: Intramyocardial implantation of of a novel mesenchymal precursor cell type (iMP).
Intramyocardial implantation of a novel mesenchymal precursor cell type (iMP).
Study Arms  ICMJE Stem cells implantation
Patients with severe coronary artery disease and chronic ischemic cardiomyopathy with a LVEF ≤40% who are scheduled for elective CABG according to accepted guidelines. Additional criteria include the following: age <75 years, history of myocardial infarction (not less than 14 days before the procedure), LVEF ≤40 % assessed with echocardiography, and a distinct area of dyskinetic or akinetic left ventricular myocardium corresponding with the infarct localization.
Intervention: Procedure: Intramyocardial implantation of of a novel mesenchymal precursor cell type (iMP).
Publications *

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: May 3, 2019)
11
Original Estimated Enrollment  ICMJE
 (submitted: December 19, 2012)
30
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age from 18 to 75 years
  • Severe coronary artery disease amenable to surgical revascularization according to current guidelines
  • History of acute myocardial infarction at least 14 days previously
  • Left ventricular ejection fraction (LVEF) ≤ 40% as assessed with echocardiography
  • Distinct area of dyskinetic or akinetic left ventricular myocardium corresponding with the infarct localization
  • Patient's informed consent obtained

Exclusion Criteria:

  • Emergency operation
  • Debilitating chronic disease (eg. malignancy or terminal renal failure)
  • Concomitant valve surgery
  • Previous cardiac surgery
  • Malignant ventricular arrhythmias
  • Haematologic disease
  • Woman in reproductive age
  • Severe psychiatric illness
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 Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01753440
Other Study ID Numbers  ICMJE AHEPA_CTL_01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kyriakos Anastasiadis, AHEPA University Hospital
Study Sponsor  ICMJE AHEPA University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kyriakos Anastasiadis, MD, PhD FETCS AHEPA University Hospital
PRS Account AHEPA University Hospital
Verification Date May 2019

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