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

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age20-80
SponsorHeartseed Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • HS-005

Treatment groups

14 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators