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Phase I trial of ADR-002K for patients with ischemic cardiomyopathy who undergo coronary artery bypass surgery

Phase I trial of ADR-002K for patients with ischemic cardiomyopathy who undergo coronary artery bypass surgery

SAWA Yoshiki

Osaka University Hospital

2-15, Yamadaoka, Suita city, Osaka, Japan

sawa-p@surg1.med.osaka-u.ac.jp

KAWAMURA Takuji

Osaka University Hospital

2-15, Yamadaoka, Suita city

+81-6-6879-3154

t-kawamura@surg1.med.osaka-u.ac.jp

Not Recruiting

Nov. 01, 2019

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

1) Patients who are clinically diagnosed with ischemic cardiomyopathy and receive CABG
2) Patients with a left ventricular ejection fraction of 40% or less by cardiac ultrasonography within 4 weeks before obtaining consent
3) Others

1) Patients who have a combination of cardiovascular disease such as severe organic valvular disease or aortic aneurysm determined by investigator or co-investigator to affect clinical trial procedure
2) Patients whose participation in a clinical trial is considered inappropriate at the discretion of the investigator or co-investigator
3) Others

Both

Ischemic cardiomyopathy undergoing coronary artery bypass surgery

Bypass surgery and ADR-002K administration

Coronary artery bypass, ischemic cardiomyopathy, adipose-derived mesenchymal stem cells

D017202

D045164

1) Adverse event and safety evaluation related to this product
2) Efficacy(exploratory)
3) Feasibility

1) Cardiac function
2) Exercise tolerance
3) Other

+81-6-6210-8290

Sept. 10, 2019

Yes

The deidentified individual subject date will be used for conference presentations,research article ,or both. If it is provided to the sponsor, it will be shared based on the agreement.

none