Clinical trial NCT01753440: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Artery Disease
Ischemic Cardiomyopathy
Keywords: coronary artery disease
heart failure
stem cells implantation
Lead sponsor: AHEPA University Hospital
Sponsor class: OTHER
First posted: 2012-12-20
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: iMP-related adverse events
timeFrame: 12 months
measure: Hypersensitivity
timeFrame: 12 months
Secondary outcomes:
measure: Scar reduction
timeFrame: 4 months
measure: Scar reduction
timeFrame: 12 months
measure: LVEF
timeFrame: 12 months
measure: Change in quality of life
timeFrame: 12 months
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: AHEPA University Hospital
Study officials:
affiliation: AHEPA University Hospital
name: Kyriakos Anastasiadis, MD, PhD FETCS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.