A Clinical Study to Evaluate the Safety and Effectiveness of MSCohi-O Lens in the Treatment of Immune-related Ocular Surface Diseases.

Immune-related ocular surface diseases are a kind of non-infectious eye disease pedigree, which is mediated by abnormal immune system function and characterized by ocular surface tissue damage. It mainly covers immune keratitis, immune disease-related dry eye, allergic keratoconjunctivitis, Thygeson superficial punctate keratitis, mucosal pemphigoid-related ocular surface damage and other clinical types, and its incidence is closely related to autoimmune disorder, abnormal immune response after infection, genetic susceptibility and environmental triggering factors. At present, there are still obvious therapeutic limitations in clinical routine treatment for immune-related ocular surface diseases. The first-line treatment plan mainly focuses on local glucocorticoid and non-steroidal anti-inflammatory drugs to inhibit inflammatory reaction. Although it can quickly control corneal edema and infiltration in acute stage, there are serious adverse reactions such as elevated intraocular pressure, cataract and corneal thinning and perforation after long-term use, which cannot meet the needs of long-term maintenance treatment. Umbilical cord mesenchymal stem cells (UCMSC) have unique immunomodulatory characteristics in inflammatory environment. Its mechanism of action is mainly to inhibit the over-activation of immune cells and reduce the content of pro-inflammatory factors by secreting soluble cytokines and regulating the release of various anti-inflammatory factors. However, under the traditional medication mode, UCMSC can not stay on the ocular surface. Our company has developed a medicine, namely MSCohi-O lens, which uses soft hydrophilic contact lens to load UCMSC, so as to realize long-term local administration on the ocular surface, make UCMSC play an immunomodulatory role locally, inhibit the over-activation of immune/inflammatory reaction, and finally treat or alleviate the symptoms of immune-related ocular surface diseases. This clinical study is expected to explore the clinical effect of MSCohi-O lens in the treatment of immune-related ocular surface diseases, and initially determine the clinical application of MSCohi-O lens in the treatment of immune-related ocular surface diseases, so as to provide new clinical schemes and treatment ideas for the treatment of immune-related ocular surface diseases.

Inclusion Criteria: 1. 18 \~ 65 years old (inclusive), regardless of gender; 2. Patients diagnosed as immune-related ocular surface diseases; 3. The symptoms of eye involvement cannot be relieved or poorly controlled after at least three months of traditional treatment (including the use of artificial tears, glucocorticoid, immunosuppressants, etc.); 4. Systemic immune diseases (if applicable) are in a stable stage; 5. Karnofsky functional status score (KPS score) \> 60 ; 6. The functions of important organs meet the following requirements: the absolute neutrophil count is ≥ 1.0× 10\^9/L; Platelets ≥ 75× 10\^9/L; Hemoglobin ≥ 10g/dl; Bilirubin ≤1.5 times ULN； ALT and AST≤3 times ULN；Serum creatinine ≤1.5 times ULN； 7. All the subjects and their partners had no birth plan within 6 months from the screening to the last administration and agreed to take effective non-drug contraceptive measures during the trial; 8. voluntarily participate in the research, understand and sign the informed consent. Exclusion Criteria: 1. those who are allergic to any component of the experimental drug; 2. The subject suffers from any unstable or uncontrolled cardiovascular, pulmonary, gastrointestinal, urogenital, blood coagulation, immunology, endocrine, metabolism or other medical diseases, and the researcher judges that it will interfere with the research results or endanger the safety of the subject; 3. Other eye diseases during screening: Other eye diseases unrelated to immune-related ocular surface diseases; Acute active fungal, bacterial or viral keratitis or conjunctivitis and other acute eye infections; Glaucoma or cataract, or other eye diseases, which the researcher evaluates may affect the efficacy and safety evaluation. 4. Have used any anti-VEGF drugs on the ocular surface within 30 days before joining the group; 5. Those who have received any eye surgery within 3 months before screening; Ophthalmic interventions that have been completely healed before admission and the researcher's judgment does not affect the research evaluation are allowed, such as cataract surgery ≥3 months and stable. 6. Patients who have a history of wearing contact lenses and cannot be removed during treatment; 7. Those who have mental disorder or cognitive disorder and cannot meet the requirements of the research plan; 8. Those who have participated in clinical trials of other new drugs within 3 months before screening; 9. The researcher believes that there is a history of systemic diseases or mental illness that may increase the risk of the subjects or affect the evaluation of the research results; 10. those who have tested positive for anti-HIV antibody or anti-Treponema pallidum specific antibody during the screening period; Or hepatitis C antibody positive, hepatitis C virus RNA positive, hepatitis B surface antigen positive, or hepatitis B core antibody positive in patients with a past history of hepatitis B, and accompanied by HBV-DNA ≥ 2000 IU/ml in recent 3 months; 11. Patients with malignant solid tumors in the past, except for the following cases: cured stage IB or lower cervical cancer, non-invasive basal cell or squamous cell skin cancer, malignant melanoma with complete remission (CR) of more than 10 years, and other malignant tumors with complete remission (CR) of more than 5 years; 12. pregnant or lactating women, or those who are positive in blood pregnancy test during screening; 13. The researcher thinks that it is not suitable to enter this experiment.