Exploratory Study of ADR-002K for Heart Failure Patients With Ischemic Heart Disease Who Undergo CABG
- Conditions
- Ischemic Heart Disease
- Interventions
- Biological: Placebo
- Registration Number
- NCT07192211
- Lead Sponsor
- Rohto Pharmaceutical Co., Ltd.
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mesenchymal stem cell Mesenchymal stem cell - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Time to the first occurrence of the cardiovascular events 2 years
- Secondary Outcome Measures
Name Time Method Late Gadolinium Enhancement (LGE) in Cardiac MRI scan 2 years Changes of LGE in the 2years after ADR-002K administration
Left Ventricular Ejection Fraction (LVEF) in Cardiac MRI scan and Echocardiography 2years Changes of LVEF in 2years after ADR-002K administration
Left Ventricular Remodeling in Cardiac MRI scan & Echocardiography 2 years 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 2 years Changes of 6-minute walk distance in 2 years after ADR-002K administration
New York Heart Association 2 years Changes of New York Heart Association in 2 years after ADR-002K administration
The Kansas City Cardiomyopathy Questionnaire（KCCQ) 2 years Changes of KCCQ scores in 2 years after ADR-002K administration
N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) 2 years Changes of N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) in 2 years after ADR-002K administration
Adverse Events 2 years Number and rate of adverse events related to this product
Minesota Living With Heart Failure Questinanaire（MLHFQ） 2 years Changes of MLHFQ scores in 2 years after ADR-002K administration