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

NCT01753440 | Completed Phase 2

• 1 other identifier: AHEPA_CTL_01
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Ischemic Cardiomyopathy

Keywords

coronary artery disease; heart failure; stem cells implantation

Outcome Measures

Primary Outcomes (2)

• 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.

  12 months

• Hypersensitivity

  Hypersensitivity reaction (fever, urticaria, hemolytic anemia, hypotension, immune thrombocytopenia)

  12 months

Secondary Outcomes (4)

• Scar reduction

  4 months

• Scar reduction

  12 months

• LVEF

  12 months

• Change in quality of life

  12 months

Study Arms (1)

Stem cells implantation

OTHER

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).

Interventions

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

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

Stem cells implantation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AHEPA University Hospital: lead

Study Sites (1)

AHEPA University Hospital

Thessaloniki, 546 36, Greece

Location

Related Publications (3)

• 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.

  PMID: 23117550 BACKGROUND

• 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.

  PMID: 21852003 BACKGROUND

• 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.

  PMID: 20600097 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Heart Failure

Interventions

Inosine Monophosphate

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Inosine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Kyriakos Anastasiadis, MD, PhD FETCS

  AHEPA University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Kyriakos Anastasiadis

Study Record Dates

• First Submitted: December 18, 2012
• First Posted: December 20, 2012
• Study Start: November 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 7, 2019

Record last verified: 2019-05

Locations

GR (1)