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Allogeneic Stem Cells Implantation Combined With Coronary Bypass Grafting in Patients With Ischemic Cardiomyopathy

This study is currently recruiting participants.
Verified December 2012 by AHEPA University Hospital
Sponsor:
Information provided by (Responsible Party):
Kyriakos Anastasiadis, AHEPA University Hospital
ClinicalTrials.gov Identifier:
NCT01753440
First received: December 18, 2012
Last updated: December 19, 2012
Last verified: December 2012
History of Changes
  Purpose

The aim of the present study is to investigate safety and efficacy of intramyocardial implantation of allogeneic mesenchymal stem cells in patients with ischemic cardiomyopathy at the time of coronary artery bypass grafting.


Condition Intervention Phase
Coronary Artery Disease
Ischemic Cardiomyopathy
 Procedure: Intramyocardial implantation of allogeneic mesenchymal stem cells
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AHEPA University Hospital:

Primary Outcome Measures:
  • Left ventricular ejection fraction [ Time Frame: one year ] [ Designated as safety issue: No ]
    Change in left ventricular ejection fraction assesed with echocardiography after intramyocardial implantation of allogeneic mesenchymal stem cells.

  • Myocardial segmental perfusion [ Time Frame: one year ] [ Designated as safety issue: No ]
    change in segmental perfusion as assesed with SPECT after intramyocardial implantation of allogeneic mesenchymal stem cells.


Secondary Outcome Measures:
  • all-cause mortality [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • all-cause morbidity [ Time Frame: one year ] [ Designated as safety issue: No ]
  • major adverse cardiac and cerebrovascular events [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Stem cells implantation
Patients with severe coronary artery disease with ischemic cardiomyopathy managed with concomitant coronary artery bypass grafting and intramyocardial administration of allogeneic mensenchymal stem cells.
 Procedure: Intramyocardial implantation of allogeneic mesenchymal stem cells
Intramyocardial implantation of allogeneic mesenchymal stem cells

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753440

Contacts
Contact: Polychronis Antonitsis, MD, DSc + 30 2310994871 antonits@auth.gr

Locations
Greece
AHEPA University Hospital Recruiting
Thessaloniki, Greece, 546 36
Contact: Polychronis Antonitsis, MD, DSc     + 30 2310 994871     antonits@auth.gr    
Principal Investigator: Polychronis Antonitsis, MD, DSc            
Sponsors and Collaborators
AHEPA University Hospital
Investigators
Principal Investigator: Kyriakos Anastasiadis, MD, DSc, FETCS AHEPA University Hospital
  More Information

Publications:

Responsible Party: Kyriakos Anastasiadis, Associate Professor Kyriakos Anastasiadis, AHEPA University Hospital
ClinicalTrials.gov Identifier: NCT01753440     History of Changes
Other Study ID Numbers: AHEPA_CTL_01
Study First Received: December 18, 2012
Last Updated: December 19, 2012
Health Authority: Greece: Ethics Committee

Keywords provided by AHEPA University Hospital:
coronary artery disease
heart failure
stem cells implantation

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ischemia
Cardiomyopathies
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013