Health Condition 1: null- Chronic Heart Failure
Conditions
Interventions
Intervention1: C Cure: 600 million to 1.2 billion cells in one session consisting of upto 20 targeted injections plus + Optimal Standard of Care.
Control Intervention1: Optimal Standard of Care: This
Sponsors
Cardio BioSciences
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age 18 and 75 2) Ischemic heart disease (if previous MI, 2 months) 3) Heart Failure NYHA class II or class III with LVEF 15% and 40% as assessed by echocardiography 4) Stable and optimal standard of care for 2 months 5) Patient is able to comply with protocol requirements including ICD implantation, bone marrow harvesting, C-Cure implantation and follow-up schedule
Exclusion criteria
Exclusion criteria: 1) Previous treatment will cell therapy 2) Myocardial revascularization by PCI or CABG within 2 months prior to enrolment 3) Planned PCI, CABG or any cardiac surgery 4) Bi-ventricular pacemaker within 6 months prior to enrolment 5) Moderate to severe aortic valve heart disease, aortic or mitral prosthetis valves 6) Left ventricular thrombus 7) LV wall thickness < 5 mm in the target territory 8) LV ventricular aneurysma 9) Stable chronic kidney dysfunction with serum creatinine > 2.5 mg/dL at two occasions during the screening period 10) Women of child bearing potential 11) Life expectancy <1 year for non heart failure related cause
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Left Ventricular Ejection Fraction (MUGA) at 6 monthsTimepoint: At 6 months follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| 8. Quality of Life at 6 months, 1 and 2 years 9. Peak VO² at 6 months 10. Composite score 5xdeltaV02-deltaLVESD at 6 months 11. Cardiovascular events (including myocardial infarction, stroke, worsening of heart failure, need for transplantation, and death due to cardiac causes) at each follow-up 12. Resting, atrial and ventricular arrhythmias at each follow-up 13. Overall cost 14. All cause mortality Timepoint: Up to 2 years; 1. Success to derive C-Cure, meeting release criteria 2. Procedural outcomes 3. Plasma BNP at 6 months, 1 and 2 years 4. 6-min walking distance at 6 months, 1 and 2 years 5. Echocardiographic parameters, including left ventricular ejection fraction, systolic and diastolic dimensions and volumes at each follow-up 6. LV volumes measured by MUGA at 6 months 7. Peak systolic pressure/end systolic volume measured by MUGA at 6 months Timepoint: Up to 2 years | — |
Countries
Belgium, India, Serbia
Contacts
Public ContactDr Bina Naik
The Heart Care Clinic
Outcome results
None listed