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Recruiting Phase 2 NCT07192211

NCT07192211 Exploratory Study of ADR-002K for Heart Failure Patients With Ischemic Heart Disease Who Undergo CABG

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Clinical Trial Summary
NCT ID NCT07192211
Status Recruiting
Phase Phase 2
Sponsor Rohto Pharmaceutical Co., Ltd.
Condition Ischemic Heart Disease
Study Type INTERVENTIONAL
Enrollment 50 participants
Start Date 2026-04-28
Primary Completion 2028-09-30

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 80 Years
Study Type INTERVENTIONAL
Interventions
Mesenchymal stem cellPlacebo

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 50 participants in total. It began in 2026-04-28 with a primary completion date of 2028-09-30.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

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.

Eligibility Criteria

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

Contact & Investigator

Central Contact

Sumito Okawa, Study Director

✉ R-regenerative_medicine@rohto.co.jp

📞 81-3-6832-6014

Principal Investigator

Shigeru Miyagawa, profesor

PRINCIPAL INVESTIGATOR

Osaka University

Frequently Asked Questions

Who can join the NCT07192211 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Ischemic Heart Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

What phase is the NCT07192211 trial and what does that mean for participants?

Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.

Is NCT07192211 currently recruiting?

Yes, NCT07192211 is actively recruiting participants. Contact the research team at R-regenerative_medicine@rohto.co.jp for enrollment information.

Where is the NCT07192211 trial being conducted?

This trial is being conducted at Osaka, Japan.

Who is sponsoring the NCT07192211 clinical trial?

NCT07192211 is sponsored by Rohto Pharmaceutical Co., Ltd.. The principal investigator is Shigeru Miyagawa, profesor at Osaka University. The trial plans to enroll 50 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: April 2026  ·  Data Methodology