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Active, Not Recruiting

NCT Number: NCT04945018

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases Ischemic Heart Disease Myocardial Ischemia Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

St. Marianna University Hospital, Kawasaki, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with resting left ventricular ejection fraction (LVEF) ≦40% based on institutional assessment on either screening cardiac MRI or echocardiographic assessment
  • New York Heart Association (NYHA) cardiac function classification of grade II or higher at screening
  • Other Criteria apply, please contact the investigator

Exclusion criteria

  • Patients screened less than 1 month after the onset of myocardial infarction
  • Patients with congenital heart disease, or cardiac sarcoidosis
  • Other Criteria apply, please contact the investigator

Treatment and study plan

HS-001 CS

Biological

Human (allogeneic) iPS-cell-derived cardiomyocyte spheroids suspension

HS-001-D needle, HS-001-D Adaptor

Device

Cardiomyocyte spheroids Dedicated Needles for Implantation and Guided Adaptors

Primary outcomes

  1. Safety and Tolerability

    Time frame: 26 weeks post-transplant

    Adverse events and safety in the 26 weeks after HS-001 CS transplantation

Secondary outcomes

  1. Left Ventricular Ejection Fraction in Cardiac MRI scan & Echocardiography

    Time frame: 26 weeks and 52 weeks post-transplant

    Left Ventricular Ejection Fraction in the 26 weeks and 52 weeks after HS-001 CS transplantation

  2. Myocardial wall motion evaluation in Echocardiography

    Time frame: 26 weeks and 52 weeks post-transplant

    Myocardial wall motion evaluation (Index of myocardial strain) in the 26 weeks and 52 weeks after HS-001 CS transplantation

  3. Myocardial blood flow in SPECT

    Time frame: 26 weeks and 52 weeks post-transplant

    Myocardial blood flow in the 26 weeks and 52 weeks after HS-001 CS transplantation

  4. Myocardial viability in SPECT

    Time frame: 26 weeks and 52 weeks post-transplant

    Myocardial viability in the 26 weeks and 52 weeks after HS-001 CS transplantation

  5. 6-minute walk distance

    Time frame: 26 weeks and 52 weeks post-transplant

    6-minute walk distance in the 26 weeks and 52 weeks after HS-001 CS transplantation

  6. Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Time frame: 26 weeks and 52 weeks post-transplant

    Kansas City Cardiomyopathy Questionnaire in the 26 weeks and 52 weeks after HS-001 CS transplantation

  7. 5-level EQ-5D version (EQ-5D-5L)

    Time frame: 26 weeks and 52 weeks post-transplant

    5-level EQ-5D version (EQ-5D-5L) in the 26 weeks and 52 weeks after HS-001 CS transplantation

  8. N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)

    Time frame: 26 weeks and 52 weeks post-transplant

    N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) in the 26 weeks and 52 weeks after HS-001 CS transplantation

Sponsors and collaborators

Lead sponsor

Heartseed Inc.

Industry

Registry information

Official study 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

Acronym: LAPiS

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jun 30, 2021
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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