NCT04945018

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

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Heartseed Inc. · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Heart Failure
• Ischemic Heart Disease

Interventions

Type	Name	Description
BIOLOGICAL	HS-001 CS	Human (allogeneic) iPS-cell-derived cardiomyocyte spheroids suspension
DEVICE	HS-001-D needle, HS-001-D Adaptor	Cardiomyocyte spheroids Dedicated Needles for Implantation and Guided Adaptors

Timeline

• Start date: 2022-04-19
• Primary completion: 2025-07-31
• Completion: 2026-01-31
• First posted: 2021-06-30
• Last updated: 2025-09-22

Locations

8 sites across 1 country: Japan