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

NCT ID: NCT07192211

Last Updated: 2025-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2029-03-31

Brief Summary

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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

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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.

Conditions

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Ischemic Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Mesenchymal stem cell

Group Type EXPERIMENTAL

Mesenchymal stem cell

Intervention Type BIOLOGICAL

ADR-002K administration

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Placebo

Interventions

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Mesenchymal stem cell

ADR-002K administration

Intervention Type BIOLOGICAL

Placebo

Placebo

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rohto Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shigeru Miyagawa, profesor

Role: PRINCIPAL_INVESTIGATOR

Osaka University

Central Contacts

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Sumito Okawa, Study Director

Role: CONTACT

81-3-6832-6014

Toshiyuki Osawa

Role: CONTACT

81-6-6447-8610

Other Identifiers

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ADR-002K-0223

Identifier Type: -

Identifier Source: org_study_id

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