Exosomes in Patients With Ocular Involvement of Sjögren's Syndrome

NCT07192666 | Not Yet Recruiting Early Phase 1

• 1 other identifier: PLKR-MSC-Exos-101
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Sjögren's Syndrome

Outcome Measures

Primary Outcomes (1)

• Adverse events (AEs)

  Incidence and severity of adverse events (AEs) from subjects receiving administration to Day 29 post-administration.

  from subjects receiving administration to Day 29 post-administration

Secondary Outcomes (4)

• CFS

  from baseline to Day 8, Day 15 and Day 29 post-administration

• TBUT

  from baseline on Day 8, Day 15 and Day 29 post-administration

• OSDI

  from baseline on Day 8, Day 15 and Day 29 post-administration

• Schirmer's test

  from baseline on Day 8, Day 15 and Day 29 post-administration

Study Arms (1)

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.

Drug: Exosome Preparation

Interventions

Exosome Preparation 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.

Also known as: Exosome

Exosome Preparation Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong ProCapZoom Biosciences Co., Ltd.: lead

MeSH Terms

Conditions

Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Jiexing Chen

CONTACT

18302002029; jxchen@procapzoom.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 25, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share