[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657401":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":18,"studyPopulation":18,"armGroups":26,"interventions":44,"overallOfficials":57,"centralContacts":64,"locations":73,"responsibleParty":90,"collaborators":18,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":18,"eligibilityCriteria":100,"healthyVolunteers":96,"sex":101,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":18,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":114,"overallStatus":118,"whyStopped":18,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Yeditepe University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Salivary Flow Rate From Baseline to Month 6 Assessed by Sialoscintigraphy","Change in salivary flow rate, measured by salivary gland scintigraphy. Salivary flow rate will be expressed in mL\u002Fmin. Baseline values obtained from the participants' existing sialoscintigraphy performed at Yeditepe University will be compared with the values obtained at Month 6.","Baseline to Month 6",[14],{"measure":15,"description":16,"timeFrame":17},"Change in Xerostomia Inventory Score","Change in xerostomia severity assessed using the 11-item Xerostomia Inventory XI. Total scores range from 11 to 55, with higher scores indicating greater severity of xerostomia. The questionnaire will be administered at Month 1 and Month 3.","3 months",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":22,"primaryPurpose":23,"observationalModel":18,"timePerspective":18,"maskingInfo":24},"RANDOMIZED","PARALLEL","Participants will be randomly assigned to one of three parallel groups: exosome, mesenchymal stem cell, or placebo. Each group will receive two applications to the bilateral submandibular glands, with the second application performed 2 weeks after the first.","TREATMENT",{"masking":25,"maskingDescription":18,"whoMasked":18},"NONE",[27,33,38],{"label":28,"type":29,"description":30,"interventionNames":31},"Exosome","EXPERIMENTAL","Participants will receive exosome injections into both submandibular glands. The exosome preparation is derived from umbilical cord-derived mesenchymal stem cells and contains 5 billion particles per 1 mL. Each submandibular gland will receive 0.5 mL at two injection sites per application. Two applications will be performed, with the second application 2 weeks after the first.",[32],"Biological: exosomes derived from human umbilical cord mesenchymal stem cells",{"label":34,"type":29,"description":35,"interventionNames":36},"Mesenchymal Stem Cells","Participants will receive mesenchymal stem cell injections into both submandibular glands. The mesenchymal stem cells are derived from umbilical cord tissue and produced by Yeditepe University at a concentration of 10 million MSCs per 1 mL. Each submandibular gland will receive 0.5 mL at two injection sites per application. Two applications will be performed, with the second application 2 weeks after the first.",[37],"Biological: Mesenchymal Stem Cells (MSC)",{"label":39,"type":40,"description":41,"interventionNames":42},"Placebo","PLACEBO_COMPARATOR","Participants will receive serum physiologic (saline) injections into both submandibular glands. Each submandibular gland will receive 0.5 mL at two injection sites per application. Two applications will be performed, with the second application 2 weeks after the first.",[43],"Other: Placebo",[45,50,54],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":18},"BIOLOGICAL","exosomes derived from human umbilical cord mesenchymal stem cells","Exosomes derived from umbilical cord-derived mesenchymal stem cells. The preparation is a cell-free extracellular vesicle product containing 5 billion particles per 1 mL. Each participant will receive 0.5 mL in each submandibular gland at two injection sites. Two applications will be performed, with the second application 2 weeks after the first.",[28],{"type":46,"name":51,"description":52,"armGroupLabels":53,"otherNames":18},"Mesenchymal Stem Cells (MSC)","Umbilical cord-derived mesenchymal stem cells (MSCs), produced by Yeditepe University, at a concentration of 10 million MSCs per 1 mL. Each bilateral submandibular gland will receive 0.5 mL at two injection sites per application. Two applications will be performed, with the second application 2 weeks after the first.",[34],{"type":6,"name":39,"description":55,"armGroupLabels":56,"otherNames":18},"Serum physiologic (saline). Each bilateral submandibular gland will receive 0.5 mL at two injection sites per application. Two applications will be performed, with the second application 2 weeks after the first.",[39],[58,61],{"name":59,"affiliation":5,"role":60},"Yavuz Selim Pata, Professor","STUDY_DIRECTOR",{"name":62,"affiliation":5,"role":63},"Banu Erkal, Resident","PRINCIPAL_INVESTIGATOR",[65,70],{"name":66,"role":67,"phone":68,"phoneExt":18,"email":69},"Banu Erkal, MD","CONTACT","+905319867061","banurkl@gmail.com",{"name":59,"role":67,"phone":71,"phoneExt":18,"email":72},"+905337602070","yavuzpata@hotmail.com",[74],{"facility":5,"status":18,"city":75,"state":76,"zip":77,"country":78,"countryCode":18,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Istanbul","Kadikoy","34718","Turkey (Türkiye)",{"type":80,"coordinates":81},"Point",[82,83],28.94966,41.01384,{"lat":83,"lon":82},[86,87,88,89],{"name":66,"role":67,"phone":68,"phoneExt":18,"email":69},{"name":18,"role":67,"phone":18,"phoneExt":18,"email":69},{"name":66,"role":63,"phone":18,"phoneExt":18,"email":18},{"name":59,"role":63,"phone":18,"phoneExt":18,"email":18},{"type":91,"investigatorFullName":92,"investigatorTitle":93,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Banu Erkal","Otorhinolaryngology Resident","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":105,"type":106},30,"ESTIMATED","INTERVENTIONAL",[109],"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.",[112,113,28],"Sjogren Syndrome","Xerostomia",[115,116,117],"sjögren syndrome","xerostomia","exosome","NOT_YET_RECRUITING","2026-09-22",{"date":121,"type":122},"2026-09-24","ACTUAL",{"date":124,"type":106},"2026-12-01",{"date":126,"type":106},"2027-12-01",{"name":92,"class":6},1]