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

NCT07347197 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: HS-005-01
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability

  Adverse events and safety in the 26 weeks after HS-005 administration

  26 weeks post-transplant

Secondary Outcomes (12)

• Left Ventricular Ejection Fraction in Cardiac MRI scan

  26 weeks and 52 weeks post-transplant

• Left Ventricular Ejection Fraction in Echocardiography

  26 weeks and 52 weeks post-transplant

• Left Ventricular volume in Cardiac MRI scan

  26 weeks and 52 weeks post-transplant

• Left Ventricular volume in Echocardiography

  26 weeks and 52 weeks post-transplant

• Myocardial wall motion evaluation in MRI

  26 weeks and 52 weeks post-transplant

Study Arms (1)

Treatment

EXPERIMENTAL

HS-005 administration

Combination Product: HS-005

Interventions

HS-005 COMBINATION_PRODUCT

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

Treatment

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heartseed Inc.: lead

MeSH Terms

Conditions

Heart Failure; Myocardial Ischemia; Cardiomyopathy, Dilated

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cardiomegaly; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Heartseed Inc.

CONTACT

+8163801068; contact@heartseed.jp

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2025
• First Posted: January 16, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 31, 2030
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share