Menu
Not yet recruiting NCT07347197

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

Phase I / Phase II Interventional Heart Failure Ischemic Heart Failure Ischemic Heart Disease Dilated Cardiomyopathy (DCM)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HS-005.
Who it may be relevant to
Registry conditions: Heart Failure, Ischemic Heart Failure, Ischemic Heart Disease, Dilated Cardiomyopathy (DCM). Basic parameters: 20 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Combination product HS-005
    Human (allogeneic) iPS-cell-derived cardiomyocyte spheroids (HS-001CS) transplantation with endocardial delivery systems

Primary outcome measures

  • Safety and Tolerability [Time frame: 26 weeks post-transplant]
Secondary outcome measures (12)
  • Left Ventricular Ejection Fraction in Cardiac MRI scan [Time frame: 26 weeks and 52 weeks post-transplant]
  • Left Ventricular Ejection Fraction in Echocardiography [Time frame: 26 weeks and 52 weeks post-transplant]
  • Left Ventricular volume in Cardiac MRI scan [Time frame: 26 weeks and 52 weeks post-transplant]
  • Left Ventricular volume in Echocardiography [Time frame: 26 weeks and 52 weeks post-transplant]
  • Myocardial wall motion evaluation in MRI [Time frame: 26 weeks and 52 weeks post-transplant]
  • Myocardial wall motion evaluation in Echocardiography [Time frame: 26 weeks and 52 weeks post-transplant]
  • Myocardial blood flow in SPECT [Time frame: 26 weeks and 52 weeks post-transplant]
  • Myocardial viability in SPECT [Time frame: 26 weeks and 52 weeks post-transplant]
  • 6-minute walk distance [Time frame: 26 weeks and 52 weeks post-transplant]
  • N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) [Time frame: 26 weeks and 52 weeks post-transplant]
  • QoL questioner (Kansas City Cardiomyopathy Questionnaire) [Time frame: 26 weeks and 52 weeks post-transplant]
  • QoL questioner (EuroQol 5 dimensions 5-level) [Time frame: 26 weeks and 52 weeks post-transplant]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07347197 · HS-005-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗