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

February 20, 2024 updated by: Heartseed Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • Kawasaki, Japan
        • Recruiting
        • St. Marianna University Hospital
      • Saitama, Japan
        • Recruiting
        • Saitama Medical University International Medical Center
      • Tokyo, Japan
        • Recruiting
        • Juntendo University Hospital
      • Tokyo, Japan
        • Recruiting
        • Nihon University Itabashi Hospital
      • Tokyo, Japan
        • Recruiting
        • The University of Tokyo Hospital
      • Tokyo, Japan
        • Recruiting
        • Tokyo Medical And Dental University Medical Hospital
      • Tokyo, Japan
        • Recruiting
        • Tokyo Metropolitan Geriatric Medical Center
      • Tokyo, Japan
        • Recruiting
        • Tokyo Women's Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HS-001 Low dose
HS-001 Low dose Administration
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
Experimental: HS-001 High dose
HS-001 High dose Administration
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability
Time Frame: 26 weeks post-transplant
Adverse events and safety in the 26 weeks after HS-001 CS transplantation
26 weeks post-transplant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
26 weeks and 52 weeks post-transplant
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
26 weeks and 52 weeks post-transplant
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
26 weeks and 52 weeks post-transplant
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
26 weeks and 52 weeks post-transplant
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
26 weeks and 52 weeks post-transplant
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
26 weeks and 52 weeks post-transplant
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
26 weeks and 52 weeks post-transplant
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
26 weeks and 52 weeks post-transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heartseed Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2022

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

June 22, 2021

First Submitted That Met QC Criteria

June 22, 2021

First Posted (Actual)

June 30, 2021

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-001-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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