Endocardial Delivery for Myocardial Regeneration Using Allogeneic iPSC-derived Cardiomyocyte Spheroids for HF With Systolic Dysfunction (EMERALD Study)
Starting soon · Phase 1/Phase 2
Conditions studied: Heart Failure, Ischemic Heart Failure, Ischemic Heart Disease, Dilated Cardiomyopathy (DCM)
In brief
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.
Key facts
- Study ID
- NCT07347197
- Run by
- Heartseed Inc.
- People needed
- 14
- Starts
- 2026-01-01
- Expected to finish
- 2030-01-31
- Last updated by the study team
- 2026-01-16
Who can join
Age: 20 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Full record on ClinicalTrials.gov
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