IPSC-CMs Combined with LVAD or CABG for the Treatment of Heart Failure

Inclusion Criteria:

• Male or female aged 35-75 years (inclusive) at the time of signing the informedconsent form.

• Capable of understanding the informed consent form, voluntarily agreeing toparticipate 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 HeartAssociation (NYHA) functional class III-IV.

• Echocardiography demonstrating regional hypokinesia or akinesia of the ventricularwall.

• Cardiac magnetic resonance imaging (MRI) confirming left ventricular ejectionfraction (LVEF) ≤35%.

• Myocardial perfusion-metabolism imaging with radionuclide indicating infarctedmyocardium in the left anterior descending (LAD) artery territory.

• Meets criteria for coronary artery bypass grafting (CABG) under cardiopulmonarybypass during screening and requires CABG surgery.

• For patients enrolled in the LVAD implantation group, the following additionalcriteria must be met:

1. Definitive indication for LVAD implantation due to end-stage heart failure.

2. Anticipated significant improvement in hemodynamic stability post-LVADimplantation, with potential for further cardiac functional improvement viamyocardial cell injection.

3. Absence of significant contraindications for LVAD surgery.

Exclusion Criteria:

• History of pacemaker, implantable cardioverter-defibrillator (ICD), or cardiacresynchronization 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 orleft atrial appendage closure/resection).

• Malignant ventricular arrhythmia.

• Contraindications for CABG surgery.

• Positive serology for human immunodeficiency virus (HIV), hepatitis B surfaceantigen (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 theprotocol-specified immunosuppressive regimen.

• Hypersensitivity to mycophenolate sodium, mycophenolic acid, mycophenolate mofetil,tacrolimus, macrolides, prednisone acetate/methylprednisolone, othercorticosteroids, 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 fortrial participation.