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

Heartseed

Status and phase

Not yet enrolling

Phase 2

Phase 1

Conditions

Ischemic Heart Disease

Dilated Cardiomyopathy (DCM)

Heart Failure

Ischemic Heart Failure

Treatments

Combination Product: HS-005

Study type

Interventional

Funder types

Industry

Identifiers

NCT07347197

HS-005-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

14 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

No 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