Overview
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.
Description
This is a multicenter, randomized, double-blind, placebo-controlled Phase II study. ADR-002K (Adipose-derived mesenchymal stem cells) is administered to the surface of the heart in patients with ischemic heart disease who undergo CABG. The efficacy and safety of ADR-002K are evaluated until the last patient has completed the 2-year evaluation.
Eligibility
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
