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Endocardial Delivery for Myocardial Regeneration Using Allogeneic iPSC-derived Cardiomyocyte Spheroids for HF With Systolic Dysfunction (EMERALD Study)
Sponsor: Heartseed Inc.
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.
Official title: A Phase I/II Study of Endocardial Delivery for Myocardial Regeneration Using Human Induced Pluripotent Stem (iPS) Cell-derived Cardiomyocyte Spheroids for Heart Failure Reduced Ejection Fraction
Key Details
Gender
All
Age Range
20 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
14
Start Date
2026-01-01
Completion Date
2030-01-31
Last Updated
2026-01-16
Healthy Volunteers
No
Interventions
HS-005
Human (allogeneic) iPS-cell-derived cardiomyocyte spheroids (HS-001CS) transplantation with endocardial delivery systems