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

Korábbi kezelés

• Acute myocardial infarction or history of percutaneous coronary intervention (PCI) within 1 month prior to screening.
• Acute cerebrovascular event within 1 month prior to screening.
• Planned concurrent major surgery (excluding left ventricular aneurysm resection or left atrial appendage closure/resection).
• Contraindications for CABG surgery.
• Contraindications to immunosuppressive therapy or inability to comply with the protocol-specified immunosuppressive regimen.
• Participation in another clinical trial within 3 months prior to screening.

Más betegség

• History of pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT).
• Severe valvular heart disease.
• History of malignancy within 5 years prior to screening.
• Autoimmune disease or chronic use of immunosuppressive agents.
• History of organ transplantation.
• Malignant ventricular arrhythmia.
• 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.
• Any other condition deemed by the investigator to render the patient unsuitable for trial participation.

Laborértékek

• Hypersensitivity to mycophenolate sodium, mycophenolic acid, mycophenolate mofetil, tacrolimus, macrolides, prednisone acetate/methylprednisolone, other corticosteroids, or basiliximab.

Egyéb

• Non-ischemic cardiomyopathy or acute viral myocarditis.
• Pregnancy, lactation, or positive pregnancy test in female patients.

• 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:
  • Definitive indication for LVAD implantation due to end-stage heart failure.
  • Anticipated significant improvement in hemodynamic stability post-LVAD implantation, with potential for further cardiac functional improvement via myocardial cell injection.
  • Absence of significant contraindications for LVAD surgery.