Stem Cell-Derived Heart Muscle Cells for Heart Failure With Weak Pumping
Tests stem cell-derived heart muscle cells delivered inside the heart in severe heart failure.
Plain-language title generated from the registry record
Registry title: Endocardial Delivery for Myocardial Regeneration Using Allogeneic iPSC-derived Cardiomyocyte Spheroids for HF With Systolic Dysfunction (EMERALD Study)
Key facts
- Where
- Kawasaki, Matsumoto, Shinagawa Ku, Shinjuku-ku, and Tsukuba, JapanSee the 5 sites
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 20 and 80 years old?
Source: NCT07347197, who can take part
Where in Japan
- St. Marianna University HospitalKawasaki, JapanTaking people
- Shinshu University HospitalMatsumoto, JapanTaking people
- Showa Medical UniversityShinagawa Ku, JapanTaking people
- Tokyo Medical University HospitalShinjuku-ku, JapanTaking people
- University of Tsukuba HospitalTsukuba, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Heartseed Inc.
- Trial code
- NCT07347197
- Record updated
- 22 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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 Criteria apply, please contact the investigator.