About this trial
ADR-002K is administered to heart failure patients with ischemic heart disease who undergo coronary artery bypass surgery (CABG) to investigate its efficacy and safety.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients clinically diagnosed with chronic heart failure due to ischemic heart disease who undergo CABG
Patients with an LVEF of less than 40% as determined by the cardiac ultrasound at the screening examination.
Others
Disqualifiers
Patients who have a combination of cardiovascular disease such as severe organic valvular disease.
Patients who have developed acute coronary syndrome within 3 months prior to obtaining consent.
Others
Trial design
Parallel
Treatments tested in this trial
Mesenchymal stem cell
Biological/VaccineADR-002K administration
Placebo
Biological/VaccinePlacebo
Treatment groups
Trial outcomes
Primary outcomes
Time to the first occurrence of the cardiovascular events
Secondary outcomes
Left Ventricular Ejection Fraction (LVEF) in Cardiac MRI scan and Echocardiography
Changes of LVEF in 2years after ADR-002K administration
Late Gadolinium Enhancement (LGE) in Cardiac MRI scan
Changes of LGE in the 2years after ADR-002K administration
Left Ventricular Remodeling in Cardiac MRI scan & Echocardiography
Changes of Left Ventricular End-Systolic Volume Index, Left Ventricular End-Diastolic Volume Index, Left Ventricular End-Systolic Diameter, Left Ventricular End-Diastolic Diameter) in 2 years after ADR-002K administration
6-minute walk distance
Changes of 6-minute walk distance in 2 years after ADR-002K administration
Sponsors and contacts
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