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MSCohi-O Lenses for Ocular Involvement in Sjögren's Syndrome
MSCohi-O Lenses for Ocular Involvement in Sjögren's Syndrome

NCT07185139

Not Yet RecruitingEARLY_Phase 1

Sponsor: Guangdong ProCapZoom Biosciences Co., Ltd.

Conditions: Sjögren's Syndrome

Interventions: MSCohi-O Lenses

This study is aSingle-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.
* Ocular signs and symptoms unresponsive to 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.