The University of Osaka Hospital
Osaka, Suita, 5650871, Japan
Location status: Recruiting
Recruiting
NCT Number: NCT07192211
Exploratory Study of ADR-002K for Heart Failure Patients With Ischemic Heart Disease Who Undergo CABG
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Mesenchymal stem cell
BiologicalADR-002K administration
Placebo
BiologicalPlacebo
Primary outcomes
-
Time to the first occurrence of the cardiovascular events
Time frame: 2 years
Secondary outcomes
-
Left Ventricular Ejection Fraction (LVEF) in Cardiac MRI scan and Echocardiography
Time frame: 2years
Changes of LVEF in 2years after ADR-002K administration
-
Late Gadolinium Enhancement (LGE) in Cardiac MRI scan
Time frame: 2 years
Changes of LGE in the 2years after ADR-002K administration
-
Left Ventricular Remodeling in Cardiac MRI scan & Echocardiography
Time frame: 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
Time frame: 2 years
Changes of 6-minute walk distance in 2 years after ADR-002K administration
-
New York Heart Association Symptoms
Time frame: 2 years
Changes of New York Heart Association in 2 years after ADR-002K administration
-
The Kansas City Cardiomyopathy Questionnaire（KCCQ)
Time frame: 2 years
Changes of KCCQ scores in 2 years after ADR-002K administration
-
Minesota Living With Heart Failure Questinanaire（MLHFQ）
Time frame: 2 years
Changes of MLHFQ scores in 2 years after ADR-002K administration
-
N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
Time frame: 2 years
Changes of N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) in 2 years after ADR-002K administration
-
Adverse Events
Time frame: 2 years
Number and rate of adverse events related to this product
Study contacts
Contact information is provided by the study sponsor or research team.
Sumito Okawa, Study Director
CONTACT
Toshiyuki Osawa
CONTACT
Sponsors and collaborators
Lead sponsor
Rohto Pharmaceutical Co., Ltd.
Industry
Registry information
Official study title
Exploratory Study of ADR-002K for Heart Failure Patients With Ischemic Heart Disease Who Undergo Coronary Artery Bypass Surgery
Important dates
- Study start
- 2026
- Primary completion
- 2028
- Study completion
- 2029
- First posted
- Sep 25, 2025
- Registry last updated
- Jun 9, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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