NCT07347197RecruitingPhase 1/2
Endocardial Delivery for Myocardial Regeneration Using Allogeneic iPSC-derived Cardiomyocyte Spheroids for HF With Systolic Dysfunction (EMERALD Study)
A Phase I/II Study of Endocardial Delivery for Myocardial Regeneration Using Human Induced Pluripotent Stem (iPS) Cell-derived Cardiomyocyte Spheroids for Heart Failure Reduced Ejection Fraction
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 endocardial delivery of HS-001 CS into severe heart failure patients with reduced ejection fraction for 26 weeks after transplantation.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 14 (estimated)
- First submitted
- 27 Dec 2025
- Start date
- 19 Jan 2026
- Primary completion date
- 1 Jan 2028
- Lead sponsor
- Heartseed Inc.
- Diseases
- Heart failure, Coronary artery disease
- NCT number
- NCT07347197
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 14
- From 19 Jan 2026 to the primary completion date, 1 Jan 2028
- 5 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 with cardiac devices such as pacemakers, implantable cardioverter defibrillators (ICDs), or cardiac resuscitation-enabled implantable cardioverter defibrillators (CRT-Ds)
- Patients with heart failure due to the primary disease hypertrophic cardiomyopathy (including the dilated phase), restrictive cardiomyopathy, amyloidosis, takotsubo cardiomyopathy, congenital heart disease, cardiac sarcoidosis, or constrictive pericarditis
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 screening echocardiographic assessment
- New York Heart Association (NYHA) cardiac function classification of grade II or III 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 (5)
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 | Recruiting |
| Shinshu University Hospital Coordinator of this site? Confirm its status | Matsumoto | Japan | Recruiting |
| Showa Medical University Coordinator of this site? Confirm its status | Shinagawa Ku | Japan | Recruiting |
| Tokyo Medical University Hospital Coordinator of this site? Confirm its status | Shinjuku-ku | Japan | Recruiting |
| University of Tsukuba Hospital Coordinator of this site? Confirm its status | Tsukuba | Japan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.