E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10064081 |
E.1.2 | Term | Heart failure NYHA class III |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10064080 |
E.1.2 | Term | Heart failure NYHA class II |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
Assess cost-effectiveness of C-Cure in comparison to optimal standard of care. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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 < 5 mm in the target territory; 11. Subject has proven high grade atrioventricular block or sustained ventricular tachycardia (VT) or ventricular fibrillation (VF) which lead to ICD delivering therapy (shock) within 3 months prior to enrolment; 12. Subject has an hemodynamically significant congenital heart disorder; 13. Subject has clinical evidence for chronic infection or active malignancy; 14. Subject has known stable chronic kidney dysfunction with serum creatinine > 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 < 1 year from non heart failure related causes; 23. Subject suffers from morbid obesity (Body Mass Index (BMI) > 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. |
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E.5 End points |
E.5.1 | 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).
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | Yes |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 25 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |