C-Cure is indicated for the treatment of heart failure (NYHA class II and III with a Left Ventricular Ejection Fraction > 15 % and <= 40%) secondary to ischemic cardiomyopathy. MedDRA version: 9.1 Level: LLT Classification code 10064081 Term: Heart failure NYHA class III MedDRA version: 9.1 Level: LLT Classification code 10064080 Term: Heart failure NYHA class II
Conditions
Interventions
Product Name: C-Cure
Product Code: C-Cure
Pharmaceutical Form: Suspension for injection
Sponsors
Cardio3 BioSciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject is = 18 and = 75 years old; 2. Subject has Heart Failure, New York Heart Association (NYHA) class II or class III with LVEF > 15% and = 40%; 3. Subject has chronic heart disease of ischemic origin (myocardial infarction > 2 months); 4. Subject has an identifiable (by transthoracic echocardiography) area of transmural scar within the left ventricle; 5. Subject is on optimal standard of care for more than 2 months; 6. Subject is willing and able to undergo an ICD implantation, prior to receiving C-Cure or already has an ICD implanted; 7. Subject agrees to comply with all follow-up evaluations; 8. Subject has been informed of the nature of the clinical trial and agrees to its provision and has provided written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subject has been treated with cell-based therapy; 2. Subject has myocardial revascularization by PCI or CABG within 2 months prior to enrolment; 3. Subject has had an MI within 2 months prior to enrolment; 4. Subject is planned for PCI, CABG or any cardiac surgery; 5. Subject is receiving biventricular pacing since less than 6 month prior to enrolment; 6. Subject has moderate to severe aortic valve heart disease, aortic or mitral prosthetic valve; 7. Subject has a significant mitral valve insufficiency (Effective Regurgitant Orifice (ERO) > 0.2 cm²) with possibility of mitral valve surgery; 8. Subject has left ventricular thrombus; 9. Subject has LV aneurysma or is a candidate for surgical aneurysmectomy; 10. Subject LV wall thickness is 2.5 mg/dL at two occasions during the screening period; 15. Subject has experienced severe adverse reaction/allergies to contrast agents, penicillin or streptomycin; 16. 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; 17. Subject is on chronic immunosuppressive transplant therapy; 18. Subject had an autologous or allogenic bone marrow or peripheral stem cell transplant or prior solid organ transplantation; 19. Subject has a multisystem disease; 20. Subject has been tested positive for Human Immunodeficiency Virus (HIV 1 or HIV 2), Hepatitis B Virus (HBV), Hepatitis C (HCV) and/or syphilis; 21. Women of child bearing potential; 22. Subject has life expectancy 40); 24. Subject has a recent history of alcohol or drug abuse; 25. Subject has any other surgical or medical condition that, in the judgment of the investigator might warrant exclusion or be contraindicated for safety reasons (e.g. unstable atrial fibrillation or recent mitral valve plasty); 26. Subject is currently participating in another trial, with the exception of observational/non interventional registries, in which written approval of Cardio3 BioSciences is needed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the C-Cure Clinical Trial is to assess the safety and efficacy of C-Cure in patients with chronic congestive heart failure secondary to ischemic cardiomyopathy.;Secondary Objective: Assess cost-effectiveness of C-Cure in comparison to optimal standard of care.;Primary end point(s): For primary endpoint assessment of C-Cure, the following parameter will be compared between the treatment group and the control group: Within-subject relative change-from-baseline at 6 month in global Left Ventricular (LV) function assessed by the change in LV ejection fraction (LVEF) measured by multi gated radionuclide blood pool acquisition (MUGA). | — |
Countries
Belgium
Outcome results
None listed