NCT04945018CompletedPhase 1/2
A Study of iPS Cell-derived Cardiomyocyte Spheroids (HS-001) in Patients With Heart Failure (LAPiS Study)
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
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 22 Jun 2021
- Start date
- 19 Apr 2022
- Primary completion date
- 31 Jul 2025
- Lead sponsor
- Heartseed Inc.
- Diseases
- Heart failure, Coronary artery disease
- NCT number
- NCT04945018
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 10
- From 19 Apr 2022 to the primary completion date, 31 Jul 2025
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients screened less than 1 month after the onset of myocardial infarction
- Patients with congenital heart disease, or cardiac sarcoidosis
Other
- Other Criteria apply, please contact the investigator
Who the study is looking for
- 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
Age in the registry: 20 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Marianna University Hospital Coordinator of this site? Confirm its status | Kawasaki | Japan | Unknown status |
| Saitama Medical University International Medical Center Coordinator of this site? Confirm its status | Saitama | Japan | Unknown status |
| Juntendo University Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Tokyo Women's Medical University Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Tokyo Medical And Dental University, Medical Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Tokyo Metropolitan Geriatric Medical Center Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| The University of Tokyo Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Nihon University Itabashi Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.