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Exosomes in Patients With Ocular Involvement of Sjögren's Syndrome
Exosomes in Patients With Ocular Involvement of Sjögren's Syndrome
Not Yet RecruitingEARLY_Phase 1
Sponsor: Guangdong ProCapZoom Biosciences Co., Ltd.
Conditions: Sjögren's Syndrome
Interventions: Exosome Preparation
This study is a single-center, multiple-dosing, prospective, nonrandom, single-arm trial.
Eligibility overview
Sex: ALL
Age: 18 Years to 65 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
Inclusion Criteria: * Aged 18-65 years old, including the boundary value, no gender restriction; * Subjects meeting the 2016 ACR/EULAR classification criteria for Sjögren's syndrome, and also meet the diagnostic criteria for ocular involvement. * 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. * Extra-ocular manifestations of Sjögren's syndrome clinically stable. * 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. * Willing to participate in the study, understand and sign the informed consent form (ICF). Exclusion Criteria: * Known allergy to any component of the investigational drug. * Active ocular infection. * 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. * History of any ocular surgery within the preceding 6 months, including cataract surgery. * Participation in another interventional clinical study. * Use of any ophthalmic medication that may interfere with the study outcomes, such as other stem-cell-derived products. * Having serious underlying diseases of the heart, brain vessels, liver, kidneys, and hematopoietic system. * 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. * Subjects deemed unsuitable for participation in this trial by the investigator.