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

RecruitingPhase 1, Phase 2Ages 20 Years - 80 YearsAllHeartseed Inc.
NCT07347197 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • HS-005
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Where

5 sites
University of Tsukuba Hospital
Tsukuba, Japan
St. Marianna University Hospital
Kawasaki, Japan
Shinshu University Hospital
Matsumoto, Japan
Showa Medical University
Shinagawa-Ku, Japan
Tokyo Medical University Hospital
Shinjuku-ku, Japan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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