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Active, not recruiting Phase 1/2

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

NCT06340048 · tracked via the Priya Life Science China tracker
Phase
Phase 1/2
Started
2023-09-05
Last updated
2026-02-10

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

HiCM-188 therapy →

HiCM-188 therapy: Epicardial Injection of Allogeneic Human Pluripotent Stem Cell-derived Cardiomyocytes (HiCM-188) during coronary artery bypass grafting surgery

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 11. Pregnancy, lactation, or a positive serum pregnancy test 12. Any other condition considered by the investigator to be inappropriate for inclusion in this clinical trial

Primary outcome measure(s)

  • The incidence of major Serious Adverse Events (SAE) — Within the first month after surgery
    The incidence of major Serious Adverse Events (SAE) within the first month after surgery, including pericardial tamponade, nonfatal myocardial infarction, stroke, and all-cause death

Trial sites (1)

FacilityCityRegionStatus
TEDA International Cardiovascular Hospital Tianjin Tianjin Municipality
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06340048 on ClinicalTrials.gov ↗ ← All trials in China