Sjögren's SyndromeEarly Phase 1NCT07192666
Exosomes in Patients With Ocular Involvement of Sjögren's Syndrome
A Early Phase 1 study testing Exosome Preparation in people with Sjögren's Syndrome, run by Guangdong ProCapZoom Biosciences Co., Ltd..
Trial summary
This study is a single-center, multiple-dosing, prospective, nonrandom, single-arm trial. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sjögren's Syndrome
- What is being tested?
- Exosome Preparation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2025to 30 Sep 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Exploratory Clinical Trial of Exosomes in Patients With Ocular Involvement of Sjögren's Syndrome
This study is a single-center, multiple-dosing, prospective, nonrandom, single-arm trial.
Read the 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
- Being tested
- Exosome Preparation
- Medical subject headings
- Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exosome PreparationDrug
Also called Exosome
Each subject will have a single designated study eye; this eye will receive multiple instillations-one drop four times daily for 14 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Exosome Preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
Incidence and severity of adverse events (AEs) from subjects receiving administration to Day 29 post-administration.
Measured: from subjects receiving administration to Day 29 post-administration
Secondary outcomes (4)
CFS
Changes in corneal fluorescein staining (CFS) scores from baseline to Day 8, Day 15 and Day 29 post-administration.
Measured: from baseline to Day 8, Day 15 and Day 29 post-administration
TBUT
Changes in Tear film break-up time (TBUT) from baseline on Day 8, Day 15 and Day 29 post-administration.
Measured: from baseline on Day 8, Day 15 and Day 29 post-administration
OSDI
Changes in ocular surface disease index (OSDI) scores from baseline on Day 8, Day 15 and Day 29 post-administration
Measured: from baseline on Day 8, Day 15 and Day 29 post-administration
Schirmer's test
Changes in Schirmer's test from baseline on Day 8, Day 15 and Day 29 post-administration.
Measured: from baseline on Day 8, Day 15 and Day 29 post-administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjögren's SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong ProCapZoom Biosciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07192666
- Sponsor's protocol ID
- PLKR-MSC-Exos-101
- Status last verified
- Sep 2025
- First submitted
- 9 Sep 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Clinical Trial of Exosomes in Patients With Ocular Involvement of Sjögren's Syndrome
- ClinicalTrials.gov ID
- NCT07192666
- Acronym / sponsor ID
- PLKR-MSC-Exos-101
- Conditions
- Sjögren's Syndrome
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Guangdong ProCapZoom Biosciences Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exosome Preparation Group | Experimental | Drug: Exosome PreparationEach subject will have a single designated study eye; this eye will receive multiple instillations-one drop four times daily for 14 consecutive days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exosome PreparationAlso: ExosomeEach 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 Group |
Primary outcome
Adverse events (AEs)
Time frame: from subjects receiving administration to Day 29 post-administration
Incidence and severity of adverse events (AEs) from subjects receiving administration to Day 29 post-administration.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Exosome Preparation in people with Sjögren's Syndrome, run by Guangdong ProCapZoom Biosciences Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiexing Chen (18302002029, jxchen@procapzoom.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs) (time frame: from subjects receiving administration to Day 29 post-administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.