C-Cure Clinical Trial

Study Overview
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Brief Summary
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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.

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

Conditions
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Heart Failure Class II or III

Intervention / Treatment
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* Biological: C-Cure


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Optimal standard of care + C-Cure | Biological: C-Cure<br>* Intraventricular injection<br>|
| No Intervention: 2<br>Optimal standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in left ventricular ejection fraction |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-min walking distance |  | 6 months, 1 and 2 years | 
| Quality of Life |  | 6 months, 1 and 2 years | 
| All cause mortality |  | Each follow-up | 
| Cardiovascular events |  | Each follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure, Cell therapy