Heart FailurePhase 1/2EMERALDNCT07347197
Endocardial Delivery for Myocardial Regeneration Using Allogeneic iPSC-derived Cardiomyocyte Spheroids for HF With Systolic Dysfunction (EMERALD Study)
A Phase 1/2 study testing HS-005 in people with Heart Failure and Ischemic Heart Failure, run by Heartseed Inc. at 5 sites in Japan.
Trial summary
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 more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Heart Failure, Ischemic Heart Failure, Ischemic Heart Disease
- What is being tested?
- HS-005
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 5 sitesJapan
- Study dates
- 19 Jan 2026to 31 Jan 2030
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Japan5 sites, 5 recruiting
- Recruiting
St. Marianna University Hospital
Kawasaki, Kanagawa, 216-8511
- Recruiting
Shinshu University Hospital
Matsumoto, Nagano, 390-8621
- Recruiting
Showa Medical University
Shinagawa-Ku, Tokyo, 142-8555
- Recruiting
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, 160-0023
- Recruiting
University of Tsukuba Hospital
Tsukuba, Ibaraki, 305-8576
About this study
Official title: 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.
Read the detailed description
This is a multicenter, open-label, phase I/II study in 14 severe heart failure patients with reduced ejection fraction.
After screening period is completed, subjects undergo HS-001 CS transplantation by endocardial delivery. After transplantation, subjects take immunosuppressant and have efficacy/safety assessments.
- Conditions
- Heart Failure, Ischemic Heart Failure, Ischemic Heart Disease, Dilated Cardiomyopathy (DCM)
- Being tested
- HS-005
- Keywords
- Heart Failure, Ischemic heart failure, Ischemic Heart Disease, Dilated Cardiomyopathy (DCM), iPSC, cell therapy
- Medical subject headings
- Heart Failure, Myocardial Ischemia, Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-005Combination product
Human (allogeneic) iPS-cell-derived cardiomyocyte spheroids (HS-001CS) transplantation with endocardial delivery systems
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | HS-005 administration Receives: Combination Product: HS-005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Adverse events and safety in the 26 weeks after HS-005 administration
Measured: 26 weeks post-transplant
Secondary outcomes (12)
Left Ventricular Ejection Fraction in Cardiac MRI scan
Left Ventricular Ejection Fraction in the 26 weeks and 52 weeks after HS-005 administration
Measured: 26 weeks and 52 weeks post-transplant
Left Ventricular Ejection Fraction in Echocardiography
Left Ventricular Ejection Fraction in the 26 weeks and 52 weeks after HS-005 administration
Measured: 26 weeks and 52 weeks post-transplant
Left Ventricular volume in Cardiac MRI scan
Left Ventricular volume in the 26 weeks and 52 weeks after HS-005 administration
Measured: 26 weeks and 52 weeks post-transplant
Left Ventricular volume in Echocardiography
Left Ventricular volume in the 26 weeks and 52 weeks after HS-005 administration
Measured: 26 weeks and 52 weeks post-transplant
Myocardial wall motion evaluation in MRI
Myocardial wall motion evaluation (Index of myocardial strain) in the 26 weeks and 52 weeks
Measured: 26 weeks and 52 weeks post-transplant
Myocardial wall motion evaluation in Echocardiography
Myocardial wall motion evaluation (Index of myocardial strain) in the 26 weeks and 52 weeks
Measured: 26 weeks and 52 weeks post-transplant
Myocardial blood flow in SPECT
Myocardial blood flow in the 26 weeks and 52 weeks
Measured: 26 weeks and 52 weeks post-transplant
Myocardial viability in SPECT
Myocardial viability in the 26 weeks and 52 weeks
Measured: 26 weeks and 52 weeks post-transplant
6-minute walk distance
6-minute walk distance in the 26 weeks and 52 weeks
Measured: 26 weeks and 52 weeks post-transplant
N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
NT-proBNP measurement in the 26 weeks and 52 weeks
Measured: 26 weeks and 52 weeks post-transplant
QoL questioner (Kansas City Cardiomyopathy Questionnaire)
KCCQ evaluation in the 26 weeks and 52 weeks
Measured: 26 weeks and 52 weeks post-transplant
QoL questioner (EuroQol 5 dimensions 5-level)
EQ-5D-5L evaluation in the 26 weeks and 52 weeks
Measured: 26 weeks and 52 weeks post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start19 Jan 2026
- Primary completion1 Jan 2028 (estimated)
- Study completion31 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heartseed Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347197
- Sponsor's protocol ID
- HS-005-01
- Acronym
- EMERALD
- Status last verified
- Oct 2026
- First submitted
- 27 Dec 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No