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A Study of iPS Cell-derived Cardiomyocyte Spheroids (HS-001) in Patients With Heart Failure (LAPiS Study) — LAPiS  

Heart Failure Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04945018
Study type Interventional
Source Heartseed Inc.
Contact Heartseed Inc.
Phone 0363801068
Email contact@heartseed.jp
Status Recruiting
Phase Phase 1/Phase 2
Start date April 19, 2022
Completion date January 31, 2026
View Details
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