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

Coronary Artery Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01753440
• Other study ID #: AHEPA_CTL_01
• Status: Completed
• Phase: Phase 2
• Start date: November 2012
• Est. completion date: December 2014

Study information

• Verified date: May 2019
• Source: AHEPA University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Coronary Artery Disease
• Coronary Disease
• Ischemia
• Ischemic Cardiomyopathy
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Greece	AHEPA University Hospital	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
AHEPA University Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (3)

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. — View 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. Erratum in: JAMA. 2013 Aug 21;310(7):750. George, Richard [added]; Lardo, Albert [added]. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Hypersensitivity	Hypersensitivity reaction (fever, urticaria, hemolytic anemia, hypotension, immune thrombocytopenia)	12 months
Secondary	Scar reduction	Myocardial scar size reduction assessed with SPECT	4 months
Secondary	Scar reduction	Myocardial scar size reduction assess with SPECT	12 months
Secondary	LVEF	Left ventricular ejection fraction	12 months
Secondary	Change in quality of life	Quality of life evaluated with MLHFQ	12 months