hiPSC-CMs-loaded Chitosan Patch to Treat Severe Chronic Ischemic Heart Disease

Inclusion criteria

• Age between 18 and 80 years (inclusive).
• Willingness and ability to give written informed consent.
• Chronic left ventricular dysfunction classified as Stage D (refractory end-stage heart failure) according to ACC staging criteria.
• NYHA functional class III-IV despite optimized guideline-directed medical therapy for heart failure.
• Indication for coronary artery bypass grafting (CABG), meeting one of the following anatomical criteria:

5.1 Class I Indications :

• Left ventricular dysfunction with significant left main coronary artery disease;
• Left ventricular dysfunction with "left main equivalent" disease (i.e., ≥70% stenosis in proximal LAD or proximal LCx);
• Left ventricular dysfunction with two- or three-vessel disease including proximal LAD stenosis.

5.2 Class IIa Indication : Left ventricular dysfunction with substantial viable, akinetic but revascularizable myocardium, not covered by above Class I anatomical criteria.

• Left ventricular ejection fraction (LVEF) ≤40% as measured by echocardiography or cardiac MRI within 6 months prior to enrollment (excluding measurements obtained within 1 month post-myocardial infarction).
• Echocardiographic evidence of regional wall motion abnormalities (hypokinesis, akinesis, or presence of ventricular aneurysm).

Exclusion criteria

Patients meeting any of the following criteria are ineligible for study participation:

• History of permanent pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT) device implantation.
• Severe valvular heart disease or prior prosthetic valve replacement.
• Prior percutaneous coronary intervention (PCI) with stent implantation.
• Chronic atrial fibrillation.
• History of sustained ventricular tachycardia or aborted sudden cardiac death.
• Baseline estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m².
• Hematocrit <25%.
• Severe contrast media allergy (anaphylactic or life-threatening reaction history).
• Coagulation disorder (INR >1.5 without therapeutic anticoagulation, platelets <50×10⁹/L, or clinically significant bleeding diathesis).
• Known hypersensitivity to penicillin or streptomycin.
• Contraindication to undergoing cardiac MRI (e.g., incompatible implanted devices, severe claustrophobia unresponsive to premedication).
• History of solid organ or bone marrow transplantation.
• Active malignancy or history of cancer within the past 5 years (except non-melanoma skin cancer or carcinoma in situ).
• Life expectancy <1 year due to non-cardiac conditions.
• Long-term systemic immunosuppressive therapy (e.g., corticosteroids, TNF-α inhibitors).
• Contraindications to immunosuppressive therapy (e.g., active infection, uncontrolled diabetes, peptic ulcer disease).
• Active infectious diseases: HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), or syphilis (Treponema pallidum, TP).
• Currently participating in another interventional clinical trial.
• Pregnant or lactating women.