C-Cure Clinical Trial
Phase 2
Completed
- Conditions
- Heart Failure Class II or III
- Registration Number
- NCT00810238
- Lead Sponsor
- Celyad Oncology SA
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in left ventricular ejection fraction 6 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (7)
CardioVascular Center
🇧🇪Aalst, Belgium
Université Catholique de Louvain, Saint-Luc
🇧🇪Brussels, Belgium
Centre Hospitalier Universitaire
🇧🇪Liège, Belgium
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Ziekenhuis Oost Limburg
🇧🇪Genk, Belgium
Virga Jesse Ziekenhuis
🇧🇪Hasselt, Belgium
Clinical Center of Serbia
🇷🇸Belgrade, Serbia
CardioVascular Center🇧🇪Aalst, Belgium