Exosomes in Patients With Ocular Involvement of Sjögren's Syndrome

Guangdong ProCapZoom Biosciences

Status and phase

Not yet enrolling

Early Phase 1

Conditions

Sjögren's Syndrome

Treatments

Drug: Exosome Preparation

Study type

Interventional

Funder types

Industry

Identifiers

NCT07192666

PLKR-MSC-Exos-101

Details and patient eligibility

About

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

Full 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.

Enrollment

12 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.