NCT04945018

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_1 heart-failure

Timeline
Completed

Started Apr 2022

Longer than P75 for phase_1 heart-failure

Geographic Reach
1 country

8 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 30, 2021

Completed
10 months until next milestone

Study Start

First participant enrolled

April 19, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

3.3 years

First QC Date

June 22, 2021

Last Update Submit

September 18, 2025

Conditions

Heart FailureIschemic Heart Disease

Keywords

Heart FailureIschemic Heart Disease

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability

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

    26 weeks post-transplant

Secondary Outcomes (8)

  • Left Ventricular Ejection Fraction in Cardiac MRI scan & Echocardiography

    26 weeks and 52 weeks post-transplant

  • Myocardial wall motion evaluation in Echocardiography

    26 weeks and 52 weeks post-transplant

  • Myocardial blood flow in SPECT

    26 weeks and 52 weeks post-transplant

  • Myocardial viability in SPECT

    26 weeks and 52 weeks post-transplant

  • 6-minute walk distance

    26 weeks and 52 weeks post-transplant

  • +3 more secondary outcomes

Study Arms (2)

HS-001 Low dose

EXPERIMENTAL

HS-001 Low dose Administration

Biological: HS-001 CSDevice: HS-001-D needle, HS-001-D Adaptor

HS-001 High dose

EXPERIMENTAL

HS-001 High dose Administration

Biological: HS-001 CSDevice: HS-001-D needle, HS-001-D Adaptor

Interventions

HS-001 CSBIOLOGICAL

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

HS-001 High doseHS-001 Low dose
HS-001-D needle, HS-001-D AdaptorDEVICE

Cardiomyocyte spheroids Dedicated Needles for Implantation and Guided Adaptors

HS-001 High doseHS-001 Low dose

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

St. Marianna University Hospital

Kawasaki, Japan

Location

Saitama Medical University International Medical Center

Saitama, Japan

Location

Juntendo University Hospital

Tokyo, Japan

Location

Nihon University Itabashi Hospital

Tokyo, Japan

Location

The University of Tokyo Hospital

Tokyo, Japan

Location

Tokyo Medical and Dental University Medical Hospital

Tokyo, Japan

Location

Tokyo Metropolitan Geriatric Medical Center

Tokyo, Japan

Location

Tokyo Women's Medical University

Tokyo, Japan

Location

MeSH Terms

Conditions

Heart FailureMyocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2021

First Posted

June 30, 2021

Study Start

April 19, 2022

Primary Completion

July 31, 2025

Study Completion

January 31, 2026

Last Updated

September 22, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

JP(8)