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

Last updated: September 18, 2025
Sponsor: Heartseed Inc.
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Heart Defect

Chest Pain

Heart Disease

Treatment

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

HS-001 CS

Clinical Study ID

NCT04945018
HS-001-01
  • Ages 20-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with resting left ventricular ejection fraction (LVEF) ≦40% based oninstitutional assessment on either screening cardiac MRI or echocardiographicassessment

  • New York Heart Association (NYHA) cardiac function classification of grade II orhigher at screening

  • Other Criteria apply, please contact the investigator

Exclusion

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 Design

Total Participants: 10
Treatment Group(s): 2
Primary Treatment: HS-001-D needle, HS-001-D Adaptor
Phase: 1/2
Study Start date:
April 19, 2022
Estimated Completion Date:
January 31, 2026

Study 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.

Connect with a study center

  • St. Marianna University Hospital

    Kawasaki,
    Japan

    Site Not Available

  • St. Marianna University Hospital

    Kawasaki 1859642,
    Japan

    Site Not Available

  • Saitama Medical University International Medical Center

    Saitama,
    Japan

    Site Not Available

  • Saitama Medical University International Medical Center

    Saitama 6940394,
    Japan

    Site Not Available

  • Juntendo University Hospital

    Tokyo,
    Japan

    Site Not Available

  • Nihon University Itabashi Hospital

    Tokyo,
    Japan

    Site Not Available

  • Sakakibara Heart Institute

    Tokyo,
    Japan

    Active - Recruiting

  • The University of Tokyo Hospital

    Tokyo,
    Japan

    Site Not Available

  • Tokyo Medical and Dental University Medical Hospital

    Tokyo,
    Japan

    Site Not Available

  • Tokyo Metropolitan Geriatric Medical Center

    Tokyo,
    Japan

    Site Not Available

  • Tokyo Women's Medical University

    Tokyo,
    Japan

    Site Not Available

  • Juntendo University Hospital

    Tokyo 1850147,
    Japan

    Site Not Available

  • Nihon University Itabashi Hospital

    Tokyo 1850147,
    Japan

    Site Not Available

  • The University of Tokyo Hospital

    Tokyo 1850147,
    Japan

    Site Not Available

  • Tokyo Medical and Dental University Medical Hospital

    Tokyo 1850147,
    Japan

    Site Not Available

  • Tokyo Metropolitan Geriatric Medical Center

    Tokyo 1850147,
    Japan

    Site Not Available

  • Tokyo Women's Medical University

    Tokyo 1850147,
    Japan

    Site Not Available

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