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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
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.
This is a multicenter, open-label, phase I/II study in 14 severe heart failure patients with reduced ejection fraction. After screening period is completed, subjects undergo HS-001 CS transplantation by endocardial delivery. After transplantation, subjects take immunosuppressant and have efficacy/safety assessments.
Age
20 - 80 years
Sex
ALL
Healthy Volunteers
No
Start Date
January 1, 2026
Primary Completion Date
January 1, 2028
Completion Date
January 31, 2030
Last Updated
January 16, 2026
14
ESTIMATED participants
HS-005
COMBINATION_PRODUCT
Lead Sponsor
Heartseed Inc.
NCT07191730
NCT07484009
Data Source & Attribution
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