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Recruiting Phase 1/2

Endocardial Delivery for Myocardial Regeneration Using Allogeneic iPSC-derived Cardiomyocyte Spheroids for HF With Systolic Dysfunction (EMERALD Study)

NCT07347197 · tracked via the Priya Life Science Japan tracker
Sponsor
Heartseed Inc
Phase
Phase 1/2
Started
2026-01-19
Last updated
2026-10-22

Condition(s) studied

Heart FailureIschemic Heart FailureIschemic Heart DiseaseDilated Cardiomyopathy (DCM)

Investigational drug(s) / intervention(s)

HS-005

HS-005: Human (allogeneic) iPS-cell-derived cardiomyocyte spheroids (HS-001CS) transplantation with endocardial delivery systems

Study summary

The purpose of this clinical study is to evaluate the safety and efficacy of endocardial delivery of HS-001 CS into severe heart failure patients with reduced ejection fraction for 26 weeks after transplantation.

Eligibility

Sex
ALL
Min age
20 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Patients with resting left ventricular ejection fraction (LVEF) ≦40% based on institutional assessment on screening echocardiographic assessment * New York Heart Association (NYHA) cardiac function classification of grade II or III at screening * Other Criteria apply, please contact the investigator Exclusion Criteria: * Patients with cardiac devices such as pacemakers, implantable cardioverter defibrillators (ICDs), or cardiac resuscitation-enabled implantable cardioverter defibrillators (CRT-Ds) * Patients with heart failure due to the primary disease hypertrophic cardiomyopathy (including the dilated phase), restrictive cardiomyopathy, amyloidosis, takotsubo cardiomyopathy, congenital heart disease, cardiac sarcoidosis, or constrictive pericarditis * Other Criteria apply, please contact the investigator

Primary outcome measure(s)

  • Safety and Tolerability — 26 weeks post-transplant
    Adverse events and safety in the 26 weeks after HS-005 administration

Trial sites (5)

FacilityCityRegionStatus
University of Tsukuba Hospital Tsukuba Ibaraki Recruiting
St. Marianna University Hospital Kawasaki Kanagawa Recruiting
Shinshu University Hospital Matsumoto Nagano Recruiting
Showa Medical University Shinagawa-Ku Tokyo Recruiting
Tokyo Medical University Hospital Shinjuku-ku Tokyo Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07347197 on ClinicalTrials.gov ↗ ← All trials in Japan