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A Study of iPS Cell-derived Cardiomyocyte Spheroids (HS-001) in Patients With Heart Failure (LAPiS Study)
Sponsor: Heartseed Inc.
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
20 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2022-04-19
Completion Date
2026-01-31
Last Updated
2025-09-22
Healthy Volunteers
No
Conditions
Interventions
HS-001 CS
Human (allogeneic) iPS-cell-derived cardiomyocyte spheroids suspension
HS-001-D needle, HS-001-D Adaptor
Cardiomyocyte spheroids Dedicated Needles for Implantation and Guided Adaptors
Locations (8)
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