Exploratory Study of ADR-002K for Heart Failure Patients With Ischemic Heart Disease Who Undergo CABG

ROHTO Pharmaceutical

Status and phase: Not yet enrolling; Phase 2

Conditions: Ischemic Heart Disease

Treatments: Biological: Mesenchymal stem cell; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07192211

ADR-002K-0223

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Mesenchymal stem cell

Experimental group

Treatment:

Biological: Mesenchymal stem cell

Placebo

Placebo Comparator group

Treatment:

Biological: Placebo