C-Cure - Safety, Feasibility and Efficacy of Guided Bone Marrow-derived Mesenchymal Cardiopoietic Cells for the Treatment of Heart Failure Secondary to Ischemic Cardiomyopathy

Celyad Oncology SA7 sites in 2 countries240 target enrollmentDecember 2008

ConditionsHeart Failure Class II or III

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Heart Failure Class II or III
Sponsor: Celyad Oncology SA
Enrollment: 240
Locations: 7
Primary Endpoint: Change in left ventricular ejection fraction
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this clinical trial is to evaluate the feasibility, safety and efficacy of left ventricular endocardial injection of guided bone marrow-derived cardiopoietic cells (C-Cure) in the setting of chronic heart failure secondary to ischemic cardiomyopathy.

Registry

clinicaltrials.gov

Start Date

December 2008

End Date

January 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Celyad Oncology SA

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject is ≥ 18 and \< 75 years old;
•Subject has Heart Failure, New York Heart Association (NYHA) class II or class III with LVEF \> 15% and ≤ 40% as assessed by transthoracic echocardiography;
•Subject has ischemic heart disease;
•Subject has an identifiable (by transthoracic echocardiography) area of transmural scar within the left ventricle;
•Subject is on optimal and stable medical therapy for more than 2 months;
•Subject is willing and able to undergo an ICD implantation, prior to receiving C-Cure™ or already has an ICD implanted;
•Subject agrees to comply with all follow-up evaluations;
•Subject has been informed of the nature of the clinical trial and agrees to its provision and has provided written informed consent.

Exclusion Criteria

•Subject has been treated with cell-based therapy;
•Subject has myocardial revascularization by PCI or CABG within 2 months prior to enrolment;
•Subject has had an MI within 2 months prior to enrolment;
•Subject is planned for PCI, CABG or any cardiac surgery;
•Subject has received a biventricular pacemaker within 6 month prior to enrolment;
•Subject has moderate to severe aortic valve heart disease, aortic or mitral prosthetic valve;
•Subject has a significant mitral valve insufficiency (Effective Regurgitant Orifice (ERO) \> 0.2 cm²) with possibility of mitral valve surgery;
•Subject has left ventricular thrombus;
•Subject has LV aneurysma or is a candidate for surgical aneurysmectomy;
•Subject LV ventricular wall thickness is \< 5 mm in the target territory;