Ischemic Heart Disease
Conditions
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.
Interventions
BIOLOGICALMesenchymal stem cell
ADR-002K administration
BIOLOGICALPlacebo
Placebo
Sponsors
Rohto Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients clinically diagnosed with chronic heart failure due to ischemic heart disease who undergo CABG 2. Patients with an LVEF of less than 40% as determined by the cardiac ultrasound at the screening examination. 3. Others
Exclusion criteria
1. Patients who have a combination of cardiovascular disease such as severe organic valvular disease. 2. Patients who have developed acute coronary syndrome within 3 months prior to obtaining consent. 3. Others
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to the first occurrence of the cardiovascular events | 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Left Ventricular Ejection Fraction (LVEF) in Cardiac MRI scan and Echocardiography | 2years | Changes of LVEF in 2years after ADR-002K administration |
| Late Gadolinium Enhancement (LGE) in Cardiac MRI scan | 2 years | Changes of LGE in the 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 Symptoms | 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 |
| Minesota Living With Heart Failure Questinanaire（MLHFQ） | 2 years | Changes of MLHFQ 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 |
Countries
Japan
Contacts
CONTACTSumito Okawa, Study Director
CONTACTToshiyuki Osawa
PRINCIPAL_INVESTIGATORShigeru Miyagawa, profesor
Osaka University
Outcome results
None listed