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Not yet recruiting NCT07192666

Exosomes in Patients With Ocular Involvement of Sjögren's Syndrome

Early Phase I Interventional Sjögren's Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exosome Preparation.
Who it may be relevant to
Registry conditions: Sjögren's Syndrome. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Exploratory Clinical Trial of Exosomes in Patients With Ocular Involvement of Sjögren's Syndrome

Overview

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.

Interventions

  • Drug 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.

Primary outcome measures

  • Adverse events (AEs) [Time frame: from subjects receiving administration to Day 29 post-administration]
Secondary outcome measures (4)
  • CFS [Time frame: from baseline to Day 8, Day 15 and Day 29 post-administration]
  • TBUT [Time frame: from baseline on Day 8, Day 15 and Day 29 post-administration]
  • OSDI [Time frame: from baseline on Day 8, Day 15 and Day 29 post-administration]
  • Schirmer's test [Time frame: from baseline on Day 8, Day 15 and Day 29 post-administration]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07192666 · PLKR-MSC-Exos-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗