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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
2026-01-19
Completion Date
2030-01-31
Last Updated
2026-10-22
Healthy Volunteers
No
Interventions
HS-005
Human (allogeneic) iPS-cell-derived cardiomyocyte spheroids (HS-001CS) transplantation with endocardial delivery systems
Locations (5)
University of Tsukuba Hospital
Tsukuba, Ibaraki, Japan
St. Marianna University Hospital
Kawasaki, Kanagawa, Japan
Shinshu University Hospital
Matsumoto, Nagano, Japan
Showa Medical University
Shinagawa-Ku, Tokyo, Japan
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, Japan