ADR-002K for Patients With Ischemic Cardiomyopathy Who Undergo Coronary Artery Bypass Surgery

Osaka University

Status and phase: Unknown; Phase 1

Conditions: D017202

Treatments: Biological: ADR-002K administration

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04695522

CVSR0006

Details and patient eligibility

About

Ischemic cardiomyopathy undergoing coronary artery bypass surgery

Enrollment: 6 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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6 participants in 2 patient groups

Group of subjects undergoing cell transplantation

Experimental group

Treatment:

Biological: ADR-002K administration

Group of subjects undergoing sham operation

Sham Comparator group

Treatment:

Biological: ADR-002K administration