NCT07347197

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sponsor: Heartseed Inc. · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
COMBINATION_PRODUCT	HS-005	Human (allogeneic) iPS-cell-derived cardiomyocyte spheroids (HS-001CS) transplantation with endocardial delivery systems

Timeline

• Start date: 2026-01-01
• Primary completion: 2028-01-01
• Completion: 2030-01-31
• First posted: 2026-01-16
• Last updated: 2026-01-16