Title
C-Cure Clinical Trial
C-Cure - Safety, Feasibility and Efficacy of Guided Bone Marrow-derived Mesenchymal Cardiopoietic Cells for the Treatment of Heart Failure Secondary to Ischemic Cardiomyopathy
Phase
Phase 2/Phase 3Lead Sponsor
CelyadStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Heart Failure Class II or IIIIntervention/Treatment
bone marrow-derived cardiopoietic cells ...Study Participants
240The 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.
Intraventricular injection
Optimal standard of care
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.