Exosomes in Patients With Ocular Involvement of Sjögren's Syndrome

NCT ID: NCT07192666

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2026-09-30

Brief Summary

This study is a single-center, multiple-dosing, prospective, nonrandom, single-arm trial.

Detailed Description

This study is a single-center, multiple-dosing, prospective, nonrandom, single-arm trial. To evaluate the clinical safety and efficacy of exosomes in patients with ocular involvement of Sjögren's syndrome.

Conditions

Sjögren's Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exosome Preparation Group

Each subject will have a single designated study eye; this eye will receive multiple instillations-one drop four times daily for 14 consecutive days.

Group Type: EXPERIMENTAL

Exosome Preparation

Intervention Type: DRUG

Each subject will have a single designated study eye; this eye will receive multiple instillations-one drop four times daily for 14 consecutive days.

Interventions

Exosome Preparation

Each subject will have a single designated study eye; this eye will receive multiple instillations-one drop four times daily for 14 consecutive days.

Intervention Type: DRUG

Other Intervention Names

Exosome

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong ProCapZoom Biosciences Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Jiexing Chen

Role: CONTACT

jxchen@procapzoom.com

18302002029

Other Identifiers

PLKR-MSC-Exos-101

Identifier Type: -

Identifier Source: org_study_id