Status:
NOT_YET_RECRUITING
MSCohi-O Lenses for Ocular Involvement in Sjögren's Syndrome
Lead Sponsor:
Guangdong ProCapZoom Biosciences Co., Ltd.
Conditions:
Sjögren's Syndrome
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
Brief Summary
This study is aSingle-center, multiple-dosing, prospective, nonrandom, single-arm trial.
Detailed Description
This study is aSingle-center, multiple-dosing, prospective, nonrandom, single-arm trial. To evaluate the clinical safety and efficacy of MSCohi-O Lenses in patients with ocular involvement of Sjögren'...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT07185139
Start Date
September 12 2025
End Date
September 30 2026
Last Update
September 22 2025
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