C-Cure Clinical Trial

• 6-min walking distance [ Time Frame: 6 months, 1 and 2 years ] [ Designated as safety issue: No ]
• Quality of Life [ Time Frame: 6 months, 1 and 2 years ] [ Designated as safety issue: No ]
• All cause mortality [ Time Frame: Each follow-up ] [ Designated as safety issue: Yes ]
• Cardiovascular events [ Time Frame: Each follow-up ] [ Designated as safety issue: Yes ]

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.

• Experimental: 1
  Optimal standard of care + C-Cure
  Intervention: Biological: C-Cure
• No Intervention: 2
  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.