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IRCT20211102052948N1 IRCT 2022-04-20 Shiraz University of Medical Sciences Evaluation of the exosome effect of Wharton jelly mesenchymal stem cells in the treatment of dry eye Effect of human umbilical cord Wharton’s jelly-derived Mesenchymal stem cells exosomes in treatment of dry eye disease in primary sjogren’s syndrome 2022-04-21 anticipated 5 Complete https://irct.ir/trial/60409 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we have two blocks, A and B. Block A is such that the patient's right eye is treated with exosome and the left eye is controlled and B block :The left eye is treated with exosome and the patient's right eye is treated Control is considered. Each time the dice are thrown, if 1, 3 and 5 come, it will be block A, and if 2, 4 and 6 come, it will be block B, and because there is a sixth chance for each person each time, it will be random. Block A: Left eye:control Right eye : Intervention Block B: Right eye:control Left eye : Intervention, Blinding description: In this three-blind study, two vials of eye drops are given to the patient, one with code A and one with code B. And only the supervisor knows which vial contains stem cell exosomes. But the researcher, patient, and clinical data analyzer are unaware of which patient's eye's eye drop contains stem cell exosomes. 1-2 Dry eye due to Sjogren's syndrome. Intervention 1: Intervention group: Wharton jelly mesenchymal stem cell-derived exosomes. Participants will receive artificial tears for 2 weeks to return to normal, then WJMSC-exo 10ug / drop, four times a day for 14 days. The next visit will be 12 weeks later. Intervention 2: Control group: placebo containing phosphate buffered saline. Participants will receive artificial tears for 2 weeks to return to normal and then 10ug / drop of placebo containing phosphate buffered saline in each drop, four times a day for 14 days. The next visit will be 12 weeks later. Yes - There is a plan to make this available What will be shared: All data related to the project and participants can be shared anonymously after the end of the study. When: Start of access period 6 months after publication of study results To whom: Faculty members of academic centers and researchers working in academic and scientific institutions Conditions: Systematic review studies and meta-analysis Where to obtain: Contact the scientific manager of the project How to obtain: Upon formal written request Comments:
public Azam Habibi
Mohammad Rasoolullah Research Tower , Khalili Ave , Mulla Sadra Ave , Shiraz
Shiraz Iran (Islamic Republic of) 7193635899 +98 71 3628 1407 A.habibi143@gmail.com Shiraz University of Medical Sciences scientific Dr. Negar Azarpira
Mohammad Rasoolullah Research Tower , Khalili Ave , Mulla Sadra Ave , Shiraz
Shiraz Iran (Islamic Republic of) 7193635899 +98 71 3628 1407 Negarazarpira@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Middle-aged women between the ages of 45 and 35 with dry eye Clinically and serologically diagnosed by an ophthalmologist, rheumatologist or internal medicine specialist with sjogren’s syndrome. Previous use of artificial tears can not relieve it. Symptoms of dry eye in at least one patient's eye include redness, dryness, burning sensation, foreign body sensation, eye discomfort, or visual fatigue. Tear discharge test (Schermer test) both eyes ≤ 10 mm / 5 min Tear break time (TBUT) will be less than 10 seconds. 35 years 45 years Female People who are allergic to any drug . Pregnant or lactating women . Patients with active fungal, bacterial or viral keratitis or conjunctivitis. People with serious heart, lung, liver or kidney disease or other incurable eye diseases such as glaucoma, uveitis. People who wear contact lenses and do not want to remove them in the study. Perform eye surgery (including cataract surgery) in the last three months. Simultaneous enrollment in other interventional clinical trials. Use of eye drops in the last 24 hours that may affect the clinical study. They have serious systemic diseases. M35.0 Sicca syndrome [Sjogren] Treatment - Other Placebo Intervention group: Wharton jelly mesenchymal stem cell-derived exosomes. Participants will receive artificial tears for 2 weeks to return to normal, then WJMSC-exo 10ug / drop, four times a day for 14 days. The next visit will be 12 weeks later. Control group: placebo containing phosphate buffered saline. Participants will receive artificial tears for 2 weeks to return to normal and then 10ug / drop of placebo containing phosphate buffered saline in each drop, four times a day for 14 days. The next visit will be 12 weeks later. Ocular Surface Disease Index (OSDI) Score. Timepoint: Before the intervention and in the Time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks after the intervention. Method of measurement: A valid questionnaire is 12 questions that will be used to measure the symptoms of dry eye. Changes in tear secretion amount. Timepoint: Before the intervention and in the time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks after the intervention. Method of measurement: Schirmer's Test. Changes in Tear break time. Timepoint: Before the intervention and in the time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks after the intervention. Method of measurement: The time required for dry spots to appear on the surface of the eye after blinking will be measured in seconds. Changes in Ocular Surface Staining. Timepoint: Before the intervention and in the time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks after the intervention. Method of measurement: Damage to the surface of the eye will be assessed using non-toxic eye dye during the slit lamp examination. Changes in conjunctiva redness score. Timepoint: Before the intervention and in the time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks after the intervention. Method of measurement: Conjunctival hyperemia will be graded separately in each eye by the researcher assigning a score of 0 to 4 per quarter. Changes in tear meniscus thickness. Timepoint: Before the intervention and in the time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks after the intervention. Method of measurement: The distance between the line of reflection along the top of the tear prism to the edge of the eyelid will be measured in millimeters. Evaluation of MMP9, EGF gene expression in tear secretions. Timepoint: Before the intervention and in the time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks after the intervention. Method of measurement: RT-PCR technique. Evaluation of MMP9 and EGF proteins in tear secretions. Timepoint: Before the intervention and in the time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks after the intervention. Method of measurement: ELISA technique. Shiraz University of Medical Sciences Approved 2022-02-28 Ethics Committee of Shiraz University of Medical Sciences The central building of Shiraz University of Medical Sciences ., in front of Palestine Ave ., Zand Ave., Shiraz . Shiraz Fars Iran (Islamic Republic of)