Clinical Trial

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

Study acronym: LAPiS
Active, Not Recruiting Phase 1/2
View on ClinicalTrials.gov →
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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2021-06-22; most recent amendment 2025-09-18.
Status change: Recruiting → Active, Not Recruiting 2025-03-10
Status change: Not Yet Recruiting → Recruiting 2022-09-12
Trial Details
NCT Number NCT04945018
Lead Sponsor Heartseed Inc.
Conditions Heart Failure, Ischemic Heart Disease
Enrollment 10 participants
Start Date 2022-04-19
Primary Completion 2025-07-31 (estimated)
Study Completion 2026-01-31 (estimated)
Updated on ClinicalTrials.gov 2025-09-22