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

Phase 2RecruitingNCT07192211

Rohto Pharmaceutical Co., Ltd.50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Ischemic Heart Disease

Interventions

Mesenchymal stem cellBIOLOGICAL

ADR-002K administration

PlaceboBIOLOGICAL

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

The University of Osaka Hospital

Osaka, Suita, Japan

RECRUITING

Outcomes

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

Changes of LVEF in 2years after ADR-002K administration

Time frame: 2years

Late Gadolinium Enhancement (LGE) in Cardiac MRI scan

Changes of LGE in the 2years after ADR-002K administration

Time frame: 2 years

Left Ventricular Remodeling in Cardiac MRI scan & Echocardiography

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

Time frame: 2 years

6-minute walk distance

Changes of 6-minute walk distance in 2 years after ADR-002K administration

Time frame: 2 years

New York Heart Association Symptoms

Changes of New York Heart Association in 2 years after ADR-002K administration

Time frame: 2 years

The Kansas City Cardiomyopathy Questionnaire（KCCQ)

Changes of KCCQ scores in 2 years after ADR-002K administration

Time frame: 2 years

Minesota Living With Heart Failure Questinanaire（MLHFQ）

Changes of MLHFQ scores in 2 years after ADR-002K administration

Central Contacts

Sumito Okawa, Study Director

CONTACT

81-3-6832-6014 R-regenerative_medicine@rohto.co.jp

Toshiyuki Osawa

CONTACT

81-6-6447-8610 R-regenerative_medicine@rohto.co.jp

Data from ClinicalTrials.gov

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