Endocardial Delivery for Myocardial Regeneration Using Allogeneic iPSC-derived Cardiomyocyte Spheroids for HF With Systolic Dysfunction (EMERALD Study) (EMERALD)

January 8, 2026 updated by: Heartseed Inc.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

14

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
HS-005 administration
Combination product: HS-005
Human (allogeneic) iPS-cell-derived cardiomyocyte spheroids (HS-001CS) transplantation with endocardial delivery systems

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heartseed Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 31, 2030

Study Registration Dates

First Submitted

December 27, 2025

First Submitted That Met QC Criteria

January 8, 2026

First Posted (Estimated)

January 16, 2026

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-005-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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