C-Cure Clinical Trial

Celyad Oncology

Status and phase

Completed

Phase 3

Phase 2

Conditions

Heart Failure Class II or III

Treatments

Biological: C-Cure

Study type

Interventional

Funder types

Industry

Identifiers

NCT00810238

C3BS-C-07-01

EudraCT 2007-007699-40

Details and patient eligibility

About

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.

Enrollment

240 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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;
Subject has proven high grade atrioventricular block or sustained ventricular tachyarrhythmias;
Subject has an hemodynamically significant congenital heart disorder;
Subject has clinical evidence for infection or active malignancy;
Subject has known stable chronic kidney dysfunction with serum creatinine > 2.5 mg/dL at two occasions during the screening period;
Subject has experienced severe adverse reaction/allergies to contrast agents;
Subject has atherosclerosis and/or tortuosity of the aorta, iliac or femoral arteries of a degree, that could impede or preclude the safe retrograde passage of the delivery catheter, in the judgment of the investigator;
Subject is on chronic immunosuppressive transplant therapy;
Subject had an autologous or allogenic bone marrow or peripheral stem cell transplant or prior solid organ transplantation;
Subject has a multisystem disease;
Subject has been tested positive for Human Immunodeficiency Virus (HIV 1 or HIV 2), Hepatitis B Virus (HBV), Hepatitis C (HCV) and/or syphilis;
Women of child bearing potential;
Subject has life expectancy < 1 year from non heart failure related causes;
Subject suffers from morbid obesity (Body Mass Index (BMI) > 40);
Subject has a recent history of alcohol or drug abuse;
Subject has any other surgical or medical condition that, in the judgment of the investigator might warrant exclusion or be contraindicated for safety reasons;
Subject is currently participating in another trial.