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NCT Number: NCT01753440

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Heart Failure Ischemic Cardiomyopathy Myocardial Ischemia Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

AHEPA University Hospital

Thessaloniki, 546 36, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intramyocardial implantation of of a novel mesenchymal precursor cell type (iMP).

Procedure

Intramyocardial implantation of a novel mesenchymal precursor cell type (iMP).

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AHEPA University Hospital

Other

Registry information

Official study 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.

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 20, 2012
Registry last updated
May 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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