ADR-002K after CABG for heart failure due to ischemic heart disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled Phase II study evaluating ADR-002K, adipose-derived mesenchymal stem cells, applied to the heart surface during CABG in patients with ischemic heart disease and reduced heart function. Participants are assigned to ADR-002K or placebo and are followed to a 2-year evaluation to assess safety and efficacy. The trial aims to determine whether ADR-002K can improve postoperative outcomes and long-term heart function. Enrollment targets patients undergoing CABG with ischemic heart failure and an ejection fraction below 40%, with certain cardiovascular exclusions applying. The study is led by Rohto Pharmaceutical Co., Ltd. with The University of Osaka Hospital as the site.

Why it matters

Who can join: the full rules

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

Where it's running

• The University of Osaka Hospital
  Osaka, Suita, Japan Recruiting

Study contacts

• Principal investigator: Shigeru Miyagawa, profesor — Osaka University
• Study coordinator: Sumito Okawa, Study Director
• Email: R-regenerative_medicine@rohto.co.jp
• Phone: 81-3-6832-6014

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.