Aerosolized Mesenchymal Stem Cell-Derived Exosomes for the Prevention and Treatment of Radiation-Induced Oral Mucositis

Exclusion Criteria

• •1. Previous radiotherapy to the head and neck region;
• •2. Head and neck surgery within the preceding 4 weeks;
• •3. Current participation in another clinical trial, or participation in another interventional study within the past 4 weeks;
• •4. Significant cardiovascular disease, including unstable angina, myocardial infarction within the past 6 months, severe arrhythmia, or heart failure (NYHA Class III-IV);
• •5. Severe hepatic or renal dysfunction, such as cirrhosis or chronic renal insufficiency (creatinine clearance \<30 mL/min);
• •6. Active systemic infection requiring antimicrobial therapy;
• •7. Autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis) requiring ongoing immunosuppressive treatment;
• •8. Severe psychiatric disorders that may impair the ability to provide informed consent or adhere to the study protocol;
• •9. Using other oral mucosal protective agents or anti-inflammatory medications that cannot be discontinued. Long-term use of immunosuppressants or corticosteroids at a prednisone-equivalent dose \>10 mg/day;
• •10. Individuals unable to comprehend the study requirements or comply with study procedures;
• •11. Any other condition that, in the judgment of the investigator, would render the patient unsuitable for participation in the study.