Sjogren's syndrome
Conditions
Interventions
Experimental Group:For the successfully enrolled subjects, the MSCohi-O lenses of the target eyes were fitted and removed according to the lens fitting and removal methods in the administration protoc
Sponsors
Heyou International Hspital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.18 to 65 years old (including the threshold), gender not limited; 2. Patients should meet the diagnostic criteria for Sjogren syndrome and the diagnostic criteria for ocular involvement in accordance with the SS classification criteria established by the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) in 2016. 3. The symptoms and signs of ocular involvement in these patients did not improve after at least three months of traditional treatment, including the use of artificial tears and glucocorticoids. 4. Other target organs of Sjogren syndrome are in a stable stage; 5. All subjects and their partners who had no plans to have children from screening to 6 months after the last administration and agreed to take effective non-pharmaceutical contraceptive measures during the trial period; 6. Voluntarily participate in the research, understand and sign the informed consent form;
Exclusion criteria
Exclusion criteria: 1.Allergic to the drug ingredients in this study. 2.Eye infection is active. 3.Before being selected, he was diagnosed with other serious eye diseases or eye injuries, such as glaucoma, uveitis, retinopathy, chemical injury, thermal burns, etc. 4.Having undergone ophthalmic surgery including cataract surgery in the last six months. 5.Have participated in other interventional clinical studies. 6.Use other eye drops that may affect this study, such as other stem cell products. 7.Combined with serious primary diseases such as heart, cerebrovascular, liver, kidney and hematopoietic system. 8.Pregnant women or lactating women who are likely to have children must use effective contraceptive methods, such as intrauterine devices, contraceptives or condoms, during the study period and at least 3 months after the administration of the study drug. 9.The researcher thinks that there are any reasons why it is not suitable to participate in the experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events within 29 days after the first administration.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes of tear secretion test from baseline on the 8 th, 15 th and 29 th day after the first administration;Changes of tear film rupture time from baseline on the 8 th, 15 th and 29 th day after the first administration;Changes of corneal fluorescein staining score from baseline on the 8 th, 15 th and 29 th day after the first administration;Changes of ocular surface disease index score (OSDI) from baseline on the 8th, 15th and 29th day after the first administration.; | — |
Countries
China
Contacts
Public ContactLiu Dachuan
Heyou Hospital, Shunde District, Foshan City
Outcome results
None listed