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Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure

Epicardial Injection of Allogeneic Human Pluripotent Stem Cell-derived Cardiomyocytes to Treat Severe Chronic Ischemic Heart Failure

NCT06340048•Help Therapeutics

View on ClinicalTrials.gov

Summary

The purpose of this clinical study is to evaluate the feasibility, safety and efficacy of intramyocardial injection of human induce pluripotent stem cell-derived cardiomyocytes (HiCM-188) during coronary artery bypass grafting (CABG) surgery in patients with severe chronic ischemic heart failure.

Detailed Description

This is a single center, open-label, three-group dose-escalation (phase I) study followed by dose-extension (phase IIa) study in up to 36 severe ischemic heart failure patients. It is estimated that up to 18 phase I patients will be received HiCM-188 intramyocardial injection during CABG surgery. The maximum number of subjects after dose escalation and dose extension studies in each dose group is 12. All the subjects need take immunosuppressant after transplantation.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥18 years
•2. Willingness and ability to give written informed consent
•3. Nuclide-myocardial metabolic perfusion imaging or Magnetic Resonance Imaging (MRI) revealed infarcted myocardium in the left anterior descending branch (LAD) coronary artery supply area
•4. LVEF\<50% as assessed by Echocardiography or LVEF≤40% as assessed by MRI
•5. Patients have indications for Coronary Artery Bypass Grafting

Exclusion Criteria

•1. Presence of a pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy device (CRT)
•2. Diagnosed with malignancy within 5 years
•3. Autoimmune disease
•4. Recipients of organ transplant.
•5. Patients undergoing other surgical operations (excluding resection of ventricular aneurysm and left atrial appendage excision/occlusion).
•6. Severe ventricular arrhythmia
•7. Contraindication to CABG surgery
•8. Contraindication to cardiac MRI or PET/CT scan.
•9. Contraindication to immunosuppressants
•10. Participation in another clinical trial within 3 months prior to screening
+2 more criteria

Locations (1)

TEDA International Cardiovascular Hospital

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

September 5, 2023

Primary Completion Date

November 10, 2026

Completion Date

May 10, 2027

Last Updated

February 10, 2026

Enrollment

ESTIMATED participants

Conditions

Heart Failure

Interventions

HiCM-188 therapy

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 10, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure

Inclusion Criteria

Exclusion Criteria

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