High dose CABG/LVAD+iPSC-CMs: CABG+1.5×10\^8 iPSC-CMs or LVAD+1.5×10\^8 iPSC-CMs
CABG/LVAD+Saline: CABG/LVAD+Saline
Study summary
This clinical trial investigates the safety, feasibility, and therapeutic potential of a combined approach using HiCM-188 cardiomyocyte injection delivered intramyocardially alongside either LVAD implantation or CABG surgery in patients with advanced ischemic heart failure.
Eligibility
Sex
ALL
Min age
35 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* Male or female aged 35-75 years (inclusive) at the time of signing the informed consent form.
* Capable of understanding the informed consent form, voluntarily agreeing to participate in the trial, and signing the informed consent form.
* Diagnosed with end-stage heart failure.
* Receiving optimized medical therapy for heart failure, with New York Heart Association (NYHA) functional class III-IV.
* Echocardiography demonstrating regional hypokinesia or akinesia of the ventricular wall.
* Cardiac magnetic resonance imaging (MRI) confirming left ventricular ejection fraction (LVEF) ≤35%.
* Myocardial perfusion-metabolism imaging with radionuclide indicating infarcted myocardium in the left anterior descending (LAD) artery territory.
* Meets criteria for coronary artery bypass grafting (CABG) under cardiopulmonary bypass during screening and requires CABG surgery.
* For patients enrolled in the LVAD implantation group, the following additional criteria must be met:
1. Definitive indication for LVAD implantation due to end-stage heart failure.
2. Anticipated significant improvement in hemodynamic stability post-LVAD implantation, with potential for further cardiac functional improvement via myocardial cell injection.
3. Absence of significant contraindications for LVAD surgery.
Exclusion Criteria:
* History of pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT).
* Severe valvular heart disease.
* Acute myocardial infarction or history of percutaneous coronary intervention (PCI) within 1 month prior to screening.
* Non-ischemic cardiomyopathy or acute viral myocarditis.
* Acute cerebrovascular event within 1 month prior to screening.
* History of malignancy within 5 years prior to screening.
* Autoimmune disease or chronic use of immunosuppressive agents.
* History of organ transplantation.
* Planned concurrent major surgery (excluding left ventricular aneurysm resection or left atrial appendage closure/resection).
* Malignant ventricular arrhythmia.
* Contraindications for CABG surgery.
* Positive serology for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or Treponema pallidum antibody.
* Inability to undergo cardiac MRI or PET/CT imaging.
* Contraindications to immunosuppressive therapy or inability to comply with the protocol-specified immunosuppressive regimen.
* Hypersensitivity to mycophenolate sodium, mycophenolic acid, mycophenolate mofetil, tacrolimus, macrolides, prednisone acetate/methylprednisolone, other corticosteroids, or basiliximab.
* Participation in another clinical trial within 3 months prior to screening.
* Pregnancy, lactation, or positive pregnancy test in female patients.
* Any other condition deemed by the investigator to render the patient unsuitable for trial participation.
Primary outcome measure(s)
6-minute walk test — baseline, 1, 3, 6, 12 months post-operation
Major Adverse Cardiovascular Events — From enrollment to the end of study at 12 months The composite endpoint events occurring during the prescribed postoperative follow-up period included cardiac death, non-fatal myocardial infarction, non-fatal stroke, and emergency target vessel revascularization (e.g., PCI or CABG), which was expressed as the percentage of subjects experiencing at least one of these events (%).
Survival rate — From enrollment to the end of study at 12 months
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.
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