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

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07347197

Acronym

EMERALD

Enrollment

Registered

2026-01-16

Start date

2026-01-01

Completion date

2030-01-31

Last updated

2026-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dilated Cardiomyopathy (DCM), Heart Failure, Ischemic Heart Disease, Ischemic Heart Failure

Keywords

Heart Failure, Ischemic heart failure, Ischemic Heart Disease, Dilated Cardiomyopathy (DCM), iPSC, cell therapy

Brief 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.

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.

Interventions

COMBINATION_PRODUCTHS-005

Human (allogeneic) iPS-cell-derived cardiomyocyte spheroids (HS-001CS) transplantation with endocardial delivery systems

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

Inclusion criteria

* 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 criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Safety and Tolerability	26 weeks post-transplant	Adverse events and safety in the 26 weeks after HS-005 administration

Secondary

Measure	Time frame	Description
Left Ventricular Ejection Fraction in Echocardiography	26 weeks and 52 weeks post-transplant	Left Ventricular Ejection Fraction in the 26 weeks and 52 weeks after HS-005 administration
Left Ventricular volume in Cardiac MRI scan	26 weeks and 52 weeks post-transplant	Left Ventricular volume in the 26 weeks and 52 weeks after HS-005 administration
Left Ventricular volume in Echocardiography	26 weeks and 52 weeks post-transplant	Left Ventricular volume in the 26 weeks and 52 weeks after HS-005 administration
Myocardial wall motion evaluation in MRI	26 weeks and 52 weeks post-transplant	Myocardial wall motion evaluation (Index of myocardial strain) in the 26 weeks and 52 weeks
Myocardial wall motion evaluation in Echocardiography	26 weeks and 52 weeks post-transplant	Myocardial wall motion evaluation (Index of myocardial strain) in the 26 weeks and 52 weeks
Left Ventricular Ejection Fraction in Cardiac MRI scan	26 weeks and 52 weeks post-transplant	Left Ventricular Ejection Fraction in the 26 weeks and 52 weeks after HS-005 administration
Myocardial viability in SPECT	26 weeks and 52 weeks post-transplant	Myocardial viability in the 26 weeks and 52 weeks
6-minute walk distance	26 weeks and 52 weeks post-transplant	6-minute walk distance in the 26 weeks and 52 weeks
N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)	26 weeks and 52 weeks post-transplant	NT-proBNP measurement in the 26 weeks and 52 weeks
QoL questioner (Kansas City Cardiomyopathy Questionnaire)	26 weeks and 52 weeks post-transplant	KCCQ evaluation in the 26 weeks and 52 weeks
QoL questioner (EuroQol 5 dimensions 5-level)	26 weeks and 52 weeks post-transplant	EQ-5D-5L evaluation in the 26 weeks and 52 weeks
Myocardial blood flow in SPECT	26 weeks and 52 weeks post-transplant	Myocardial blood flow in the 26 weeks and 52 weeks

Contacts

Primary ContactHeartseed Inc.

contact@heartseed.jp+8163801068

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026