c-cure clinical trial

Conditions: Heart Failure Class II or III

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.


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; * 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.

Keywords: heart failure cell therapy