[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607754":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":22,"locations":21,"responsibleParty":28,"collaborators":21,"id":30,"slug":31,"hasResults":32,"nctId":33,"briefTitle":34,"officialTitle":35,"acronym":21,"eligibilityCriteria":36,"healthyVolunteers":32,"sex":37,"minAge":38,"maxAge":39,"enrollmentInfo":40,"targetDuration":21,"studyType":43,"phases":44,"briefSummary":46,"conditions":47,"keywords":21,"overallStatus":49,"whyStopped":21,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":21},{"fullName":5,"class":6},"Guangdong ProCapZoom Biosciences Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Exosome Preparation Group","EXPERIMENTAL","Each subject will have a single designated study eye; this eye will receive multiple instillations-one drop four times daily for 14 consecutive days.",[13],"Drug: Exosome Preparation",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":19},"DRUG","Exosome Preparation",[9],[20],"Exosome",null,[23],{"name":24,"role":25,"phone":26,"phoneExt":21,"email":27},"Jiexing Chen","CONTACT","18302002029","jxchen@procapzoom.com",{"type":29,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100607754","early-phase-1-exosomes-in-patients-with-ocular-involvement-of-sjgrens-syndrome-100607754",false,"NCT07192666","Exosomes in Patients With Ocular Involvement of Sjögren's Syndrome","Exploratory Clinical Trial of Exosomes in Patients With Ocular Involvement of Sjögren's Syndrome","Inclusion Criteria:\n\n* Aged 18-65 years old, including the boundary value, no gender restriction;\n* Subjects meeting the 2016 ACR\u002FEULAR classification criteria for Sjögren's syndrome, and also meet the diagnostic criteria for ocular involvement.\n* The ocular involvement symptoms and signs of these patients cannot be relieved after at least 3 months of conventional therapy, including artificial tears and topical or systemic corticosteroids.\n* Extra-ocular manifestations of Sjögren's syndrome clinically stable.\n* Subjects and their partners agree to use effective non-pharmacological contraception from screening through 6 months after the last dose and have no plans for conception during this period.\n* Willing to participate in the study, understand and sign the informed consent form (ICF).\n\nExclusion Criteria:\n\n* Known allergy to any component of the investigational drug.\n* Active ocular infection.\n* Presence of other significant ocular disease or trauma diagnosed prior to enrollment, including but not limited to glaucoma, uveitis, retinopathy, chemical injury, or thermal burns.\n* History of any ocular surgery within the preceding 6 months, including cataract surgery.\n* Participation in another interventional clinical study.\n* Use of any ophthalmic medication that may interfere with the study outcomes, such as other stem-cell-derived products.\n* Having serious underlying diseases of the heart, brain vessels, liver, kidneys, and hematopoietic system.\n* Pregnant or lactating women; women of childbearing potential must employ an effective contraceptive method (e.g., intrauterine device, oral contraceptive, or condom) during the study and for at least 3 months after the final dose of study drug.\n* Subjects deemed unsuitable for participation in this trial by the investigator.","ALL","18 Years","65 Years",{"count":41,"type":42},12,"ESTIMATED","INTERVENTIONAL",[45],"EARLY_PHASE1","This study is a single-center, multiple-dosing, prospective, nonrandom, single-arm trial.",[48],"Sjögren's Syndrome","NOT_YET_RECRUITING","2025-09-17",{"date":52,"type":53},"2025-09-25","ACTUAL",{"date":55,"type":42},"2025-09-15",{"date":57,"type":42},"2026-09-30",{"name":5,"class":6}]