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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

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Ischemic Cardiomyopathy Procedure: Intramyocardial implantation of of a novel mesenchymal precursor cell type (iMP). Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (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.
Actual Study Start Date : November 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Procedure: Intramyocardial implantation of of a novel mesenchymal precursor cell type (iMP).
Intramyocardial implantation of a novel mesenchymal precursor cell type (iMP).




Primary Outcome Measures :
  1. 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.

  2. Hypersensitivity [ Time Frame: 12 months ]
    Hypersensitivity reaction (fever, urticaria, hemolytic anemia, hypotension, immune thrombocytopenia)


Secondary Outcome Measures :
  1. Scar reduction [ Time Frame: 4 months ]
    Myocardial scar size reduction assessed with SPECT

  2. Scar reduction [ Time Frame: 12 months ]
    Myocardial scar size reduction assess with SPECT

  3. LVEF [ Time Frame: 12 months ]
    Left ventricular ejection fraction

  4. Change in quality of life [ Time Frame: 12 months ]
    Quality of life evaluated with MLHFQ



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01753440


Locations
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Greece
AHEPA University Hospital
Thessaloniki, Greece, 546 36
Sponsors and Collaborators
AHEPA University Hospital
Investigators
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Principal Investigator: Kyriakos Anastasiadis, MD, PhD FETCS AHEPA University Hospital

Publications:
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Responsible Party: Kyriakos Anastasiadis, Professor Kyriakos Anastasiadis, AHEPA University Hospital
ClinicalTrials.gov Identifier: NCT01753440     History of Changes
Other Study ID Numbers: AHEPA_CTL_01
First Posted: December 20, 2012    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019

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

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