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

NCT ID: NCT07347197

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2030-01-31

Brief Summary

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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

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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

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

HS-005 administration

Group Type EXPERIMENTAL

HS-005

Intervention Type COMBINATION_PRODUCT

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

Interventions

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HS-005

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

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heartseed Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Heartseed Inc.

Role: CONTACT

+8163801068

Other Identifiers

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HS-005-01

Identifier Type: -

Identifier Source: org_study_id

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