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

Primary Purpose

Coronary Artery Disease, Ischemic Cardiomyopathy

Status
Completed
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Intramyocardial implantation of of a novel mesenchymal precursor cell type (iMP).
Sponsored by
AHEPA University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring coronary artery disease, heart failure, stem cells implantation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AHEPA University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Stem cells implantation

Arm Description

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.

Outcomes

Primary Outcome Measures

iMP-related adverse events
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
Hypersensitivity reaction (fever, urticaria, hemolytic anemia, hypotension, immune thrombocytopenia)

Secondary Outcome Measures

Scar reduction
Myocardial scar size reduction assessed with SPECT
Scar reduction
Myocardial scar size reduction assess with SPECT
LVEF
Left ventricular ejection fraction
Change in quality of life
Quality of life evaluated with MLHFQ

Full Information

First Posted
December 18, 2012
Last Updated
May 3, 2019
Sponsor
AHEPA University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01753440
Brief Title
Allogeneic Stem Cells Implantation Combined With Coronary Bypass Grafting in Patients With Ischemic Cardiomyopathy
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
November 2012 (Actual)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
AHEPA University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Ischemic Cardiomyopathy
Keywords
coronary artery disease, heart failure, stem cells implantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stem cells implantation
Arm Type
Other
Arm Description
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 Type
Procedure
Intervention Name(s)
Intramyocardial implantation of of a novel mesenchymal precursor cell type (iMP).
Intervention Description
Intramyocardial implantation of a novel mesenchymal precursor cell type (iMP).
Primary Outcome Measure Information:
Title
iMP-related adverse events
Description
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.
Time Frame
12 months
Title
Hypersensitivity
Description
Hypersensitivity reaction (fever, urticaria, hemolytic anemia, hypotension, immune thrombocytopenia)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Scar reduction
Description
Myocardial scar size reduction assessed with SPECT
Time Frame
4 months
Title
Scar reduction
Description
Myocardial scar size reduction assess with SPECT
Time Frame
12 months
Title
LVEF
Description
Left ventricular ejection fraction
Time Frame
12 months
Title
Change in quality of life
Description
Quality of life evaluated with MLHFQ
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyriakos Anastasiadis, MD, PhD FETCS
Organizational Affiliation
AHEPA University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
AHEPA University Hospital
City
Thessaloniki
ZIP/Postal Code
546 36
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
23117550
Citation
Hare JM, Fishman JE, Gerstenblith G, DiFede Velazquez DL, Zambrano JP, Suncion VY, Tracy M, Ghersin E, Johnston PV, Brinker JA, Breton E, Davis-Sproul J, Schulman IH, Byrnes J, Mendizabal AM, Lowery MH, Rouy D, Altman P, Wong Po Foo C, Ruiz P, Amador A, Da Silva J, McNiece IK, Heldman AW, George R, Lardo A. Comparison of allogeneic vs autologous bone marrow-derived mesenchymal stem cells delivered by transendocardial injection in patients with ischemic cardiomyopathy: the POSEIDON randomized trial. JAMA. 2012 Dec 12;308(22):2369-79. doi: 10.1001/jama.2012.25321. Erratum In: JAMA. 2013 Aug 21;310(7):750. George, Richard [added]; Lardo, Albert [added].
Results Reference
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PubMed Identifier
21852003
Citation
Anastasiadis K, Antonitsis P, Doumas A, Koliakos G, Argiriadou H, Vaitsopoulou C, Tossios P, Papakonstantinou C, Westaby S. Stem cells transplantation combined with long-term mechanical circulatory support enhances myocardial viability in end-stage ischemic cardiomyopathy. Int J Cardiol. 2012 Mar 22;155(3):e51-3. doi: 10.1016/j.ijcard.2011.07.062. Epub 2011 Aug 17. No abstract available.
Results Reference
background
PubMed Identifier
20600097
Citation
Menasche P. Cardiac cell therapy: lessons from clinical trials. J Mol Cell Cardiol. 2011 Feb;50(2):258-65. doi: 10.1016/j.yjmcc.2010.06.010. Epub 2010 Jun 30.
Results Reference
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Allogeneic Stem Cells Implantation Combined With Coronary Bypass Grafting in Patients With Ischemic Cardiomyopathy

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