Sjögren's syndrome
Conditions
Interventions
Experimental Group:Treatment with MSC-EXO Eye Drops
Control Group:The control group uses a placebo (0.9% sodium chloride injection) that is indistinguishable from the experimental group in terms of appearance and sme
Sponsors
The First Affiliated Hospital of Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this clinical study; 2. Gender is not limited, age 18~70 years old; 3. Patients should meet the diagnostic conditions for Sjögren's syndrome according to the SS classification criteria developed by the American College of Rheumatology ACR./European League Against Rheumatism EULAR. in 2016, and meet the diagnostic conditions for dry eye according to the 2020 Chinese Dry Eye Expert Consensus. 4. These patients have dry eye symptoms and signs at least three months of traditional treatment including the use of artificial tears, glucocorticoids, and punctal embolization. posterior inability to resolve; 5. Other target organs of Sjögren's syndrome are in a stable phase; 6. During the follow-up period, the systemic immunomodulatory drugs of these patients will not be adjusted; 7. Selection of the study eye: The patient was examined and treated in both eyes.
Exclusion criteria
Exclusion criteria: 1. Allergy to the drug components of this study; 2. The ocular infection is in the active phase; 3. Diagnosed with other serious eye diseases or ocular trauma before enrollment, such as glaucoma, uveitis, retinopathy, chemical injury, thermal burns, etc.; 4. Have undergone eye surgery, including cataract surgery, in the past six months. 5. Have participated in other interventional clinical studies; 6. Use of other eye drops that may affect this study, such as other stem cell products; 7. Serious primary diseases such as heart, cerebrovascular, liver, kidney and hematopoietic system; 8. Pregnant or lactating women, female subjects with childbearing potential must use an effective method of contraception, such as an intrauterine device, contraceptive pill, or condom, during the study and for at least 3 months after study drug administration. 9. Those who are considered by the investigator to have any reasons for not being suitable to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjects showed a significant increase in tear production; | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in OSDI scores;Reduction in redness; | — |
Countries
China
Contacts
Public ContactLi Shiying
The First Affiliated Hospital of Xiamen University
Outcome results
None listed