[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Banu Erkal\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":46},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100657401","phase-2-exosome-and-mesenchymal-stem-cell-treatment-for-salivary-gland-dysfunction-in-primary-sjgren-syndrome-100657401",false,"NCT07838454","Exosome and Mesenchymal Stem Cell Treatment for Salivary Gland Dysfunction in Primary Sjögren Syndrome","Effect of Exosome and Mesenchymal Stem Cell Injections Into the Submandibular Glands on Salivary Gland Function in Primary Sjögren Syndrome: A Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Diagnosis of primary Sjögren syndrome\n* Salivary gland hypofunction and\u002For xerostomia\n* Previous sialoscintigraphy performed at Yeditepe University as part of the diagnosis of primary Sjögren syndrome\n* Willingness to provide written informed consent\n* Acceptance of the planned bilateral submandibular gland applications and follow-up\n\nExclusion Criteria:\n\n* Age younger than 18 years\n* No previous sialoscintigraphy or inability to undergo sialoscintigraphy\n* Presence of another disease, in addition to primary Sjögren syndrome, that may cause dry mouth\n* Use of medications that may cause dry mouth\n* Refusal to provide informed consent\n* Refusal to undergo the planned bilateral submandibular gland applications or follow-up","ALL","18 Years","65 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study will evaluate the effects of exosome and mesenchymal stem cell injections into the submandibular glands of adults with primary Sjögren syndrome and salivary gland dysfunction or dry mouth. A total of 30 participants will be randomly assigned to three groups: an exosome group, a mesenchymal stem cell group, or a placebo group. Both submandibular glands will receive two applications, with the second application performed 2 weeks after the first. Each gland will receive 0.5 mL of the assigned treatment at two injection sites. Exosomes will be derived from umbilical cord-derived mesenchymal stem cells, and mesenchymal stem cells will also be derived from umbilical cord tissue. The placebo group will receive saline. Previous sialoscintigraphy results obtained at Yeditepe University as part of the diagnosis of primary Sjögren syndrome will be used as the baseline assessment. The Xerostomia Inventory will be administered at months 1 and 3, and sialoscintigraphy will be repeated at month 6 to evaluate changes in salivary gland function. Each participant will be followed for 6 months.",[27,28,29],"Sjogren Syndrome","Xerostomia","Exosome",[31,32,33],"sjögren syndrome","xerostomia","exosome","NOT_YET_RECRUITING","2026-09-22",{"date":37,"type":38},"2026-09-24","ACTUAL",{"date":40,"type":21},"2026-12-01",{"date":42,"type":21},"2027-12-01",{"name":44,"class":45},"Banu Erkal","OTHER",""]