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A Phase I/II Study of Human Induced Pluripotent Stem (iPS) Cell-derived Cardiomyocyte Spheroids (HS-001) in Patients With Severe Heart Failure, Secondary to Ischemic Heart Disease
The purpose of this clinical study is to evaluate the safety and efficacy of HS-001 CS transplanted into severe heart failure patients with underlying ischemic heart disease for 26 weeks after transplantation.
This is a multicenter, open-label, two-group dose-escalation, phase I/II study in 10 severe heart failure patients (five in the low-dose group and five in the high-dose group) with underlying ischemic heart disease. After screening period is completed, subjects undergo HS-001 CS transplantation. After transplantation, subjects take immunosuppressant and have efficacy/safety assessments.
Age
20 - 80 years
Sex
ALL
Healthy Volunteers
No
St. Marianna University Hospital
Kawasaki, Japan
Saitama Medical University International Medical Center
Saitama, Japan
Juntendo University Hospital
Tokyo, Japan
Nihon University Itabashi Hospital
Tokyo, Japan
The University of Tokyo Hospital
Tokyo, Japan
Tokyo Medical and Dental University Medical Hospital
Tokyo, Japan
Tokyo Metropolitan Geriatric Medical Center
Tokyo, Japan
Tokyo Women's Medical University
Tokyo, Japan
Start Date
April 19, 2022
Primary Completion Date
July 31, 2025
Completion Date
January 31, 2026
Last Updated
September 22, 2025
10
ESTIMATED participants
HS-001 CS
BIOLOGICAL
HS-001-D needle, HS-001-D Adaptor
DEVICE
Lead Sponsor
Heartseed Inc.
NCT07484009
NCT07191730
Data Source & Attribution
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