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

Exclusion Criteria

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