Dry Eye DiseaseEarly Phase 1NCT07623382
Human Umbilical Cord Mesenchymal Stem Cell-derived Small Extracellular Vesicles for the Treatment of Dry Eye Disease
A Early Phase 1 study testing Human umbilical cord mesenchymal stem cell-derived small extracellular vesicle (sEV) eye drops. in people with Dry Eye Disease and Umbilical Cord Mesenchymal Stem Cell-derived Small Extracellular Vesicles, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial summary
This clinical trial aims to preliminarily evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell small extracellular vesicle eye drops in patients with dry eye disease. 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease, Umbilical Cord Mesenchymal Stem Cell-derived Small Extracellular Vesicles
- What is being tested?
- Human umbilical cord mesenchymal stem cell-derived small extracellular vesicle (sEV) eye drops.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2026to 30 Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who voluntarily participate and sign the informed consent form, are willing to comply with the treatment schedule specified in the study protocol, and attend follow-up visits on time.
- Aged ≥ 18 years, with no gender restriction.
- Best-corrected visual acuity (BCVA) of both eyes (OU) ≥ 0.1 at the Screening Visit (Visit 1, V1).
- History of dry eye disease in both eyes prior to the Screening Visit (Visit 1, V1), with at least one of the following subjective symptoms: ocular dryness, foreign body sensation, burning sensation, eye fatigue, discomfort, redness, or fluctuating visual acuity.
- Meeting one of the following criteria at the Screening Visit (Visit 1, V1):
- Positive corneal fluorescein staining, TBUT < 10 s, and OSDI score ≥ 13; ii. Negative corneal fluorescein staining, TBUT < 5 s, and OSDI score ≥ 13
Who cannot join
- Subjects with current ocular herpes or any other ocular infection or inflammation, or a history of ocular herpes or any other ocular infection within 30 days prior to screening.
- Subjects with ocular diseases including structural abnormalities of the eyelid margin (ectropion, entropion, eyelid laxity, etc.), severe conjunctivochalasis, Salzmann nodular corneal degeneration, damaged conjunctival goblet cells (e.g., vitamin A deficiency), progressive pterygium, wet age-related macular degeneration (wAMD), glaucoma, diabetic retinopathy, retinal vein occlusion, etc., which, in the investigator's opinion, may increase subject risk or interfere with study outcomes.
- Subjects with secondary ocular scarring that, in the investigator's assessment, may affect subject compliance or outcome evaluation (e.g., radiation scars, chemical burns, Stevens-Johnson syndrome, cicatricial pemphigoid, etc.).
- Subjects with secondary Sjögren's syndrome or other autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.), unless the subject meets all of the following conditions:
- Not receiving steroids, immunomodulatory, or immunosuppressive agents for the disease;
- The investigator determines that the medical condition will not impact study results.
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- Subjects with a history of organ or bone marrow transplantation.
- Subjects who wore contact lenses within 30 days prior to screening.
- Subjects who received physical therapy for dry eye within 30 days prior to screening, including eyelid scrubbing, meibomian gland expression, warm compresses, fuming, or IPL laser therapy for bilateral dry eye.
- Subjects who received oral aspirin or aspirin-containing medications, or used NSAIDs (topical ocular or systemic), or drugs known to induce ocular dryness (e.g., anticholinergics, SSRIs, etc.) within 30 days before dosing, unless the subject has been on a stable dose of such medication for at least 30 days before the baseline visit, with no expected changes during the study.
- Subjects who used the following medications within the specified periods before dosing:
- Antihistamines (ocular or systemic) or any topical ophthalmic medications within 14 days before dosing;
- Artificial tears within 14 days before dosing;
- Steroids or mast cell stabilizers (ocular or systemic) within 30 days before dosing;
- Varenicline or diquafosol within 30 days before dosing;
- Topical ocular cyclosporine or tacrolimus within 6 weeks before dosing.
- Subjects with punctal plugs implantation or a history of punctal cautery within 12 weeks prior to screening.
- Subjects who used antiglaucoma medications within 3 months prior to screening, had non-laser glaucoma surgery, or underwent glaucoma laser surgery within 6 months prior to the screening visit.
- Subjects who underwent Nd:YAG laser capsulotomy within 6 months prior to screening, or corneal refractive surgery (e.g., LASIK) within 12 months prior to screening.
- Subjects with known allergy to fluorescein, multiple drug allergies, or severe allergic diseases.
- Subjects with other poorly controlled clinical conditions, such as severe chronic infection, severe cardiopulmonary disease, uncontrolled hypertension (defined as systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg despite antihypertensive treatment), uncontrolled diabetes mellitus, malignant tumors, etc.
- Female subjects with a positive pregnancy test or lactating subjects; female subjects of childbearing potential or male subjects whose partners are of childbearing potential who are unwilling to use contraception during the study and for 1 month after the last dose of study medication.
- Subjects who participated in any other clinical trial of investigational drugs or devices within 30 days prior to screening.
- Any other conditions deemed by the investigator to make the subject ineligible for enrollment (e.g., depression, etc.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, China, 361000
Shiying Li, 0592-2137251, shiying_li@126.com
About this study
Official title: Clinical Study on the Treatment of Dry Eye With Human Umbilical Cord Mesenchymal Stem Cell-derived Small Extracellular Vesicles Eye Drops
This clinical trial aims to preliminarily evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell small extracellular vesicle eye drops in patients with dry eye disease.
- Human mesenchymal stem cell small extracellular vesicle eye drops: Administer one drop each time, 4 times daily, for a treatment duration of 4 weeks.
- During treatment, subjects will be followed up and undergo examinations and related tests weekly.
- After completion of treatment, follow-up visits will be conducted every 2 weeks for a total of 2 visits.
- Subsequently, subjects will enter a long-term follow-up period, with follow-up assessments at 3 months and 6 months to observe longer-term safety and efficacy.
- Subjects shall record medication usage and any possible adverse reactions.
- Conditions
- Dry Eye Disease, Umbilical Cord Mesenchymal Stem Cell-derived Small Extracellular Vesicles
- Being tested
- Human umbilical cord mesenchymal stem cell-derived small extracellular vesicle (sEV) eye drops.
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human umbilical cord mesenchymal stem cell-derived small extracellular vesicle (sEV) eye drops.Biological
Product: Human umbilical cord mesenchymal stem cell-derived small extracellular vesicle (sEV) eye drops.
Dosage Form: Sterile ophthalmic solution. Dosing Regimen: Instill one drop into the affected eye(s) four times daily for a treatment duration of 4 weeks.
Administration Route: Topical ocular instillation.
Follow-up Schedule:
Weekly follow-up during the 4-week treatment period. Post-treatment follow-up at Week 6 and Week 8 (every 2 weeks for 2 visits). Long-term follow-up at Month 3 and Month 6 to evaluate sustained safety and efficacy.
| Study group | Role | What they receive |
|---|---|---|
| Using Human mesenchymal stem cell small extracellular Vesicles to treat dry eye | Experimental | Not described Receives: Biological: Human umbilical cord mesenchymal stem cell-derived small extracellular vesicle (sEV) eye drops. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Corneal Fluorescein Staining Score (TCSS)
To Evaluate Changes in the Total Corneal Fluorescein Staining Score (TCSS) in Subjects
Measured: 4 Weeks
Tear Film Break-up Time (TBUT)
To Observe Changes in Tear Film Break-up Time (TBUT) in Subjects
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start31 Mar 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies 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
- Model description
- This study employs a self-controlled design . Specifically, there will be a single treatment group, and participants will serve as their own controls by comparing pre- and post-enrollment data
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Xiamen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07623382
- Sponsor's protocol ID
- FirstAHXiamenU
- Status last verified
- Feb 2026
- First submitted
- 19 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- 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 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Treatment of Dry Eye With Human Umbilical Cord Mesenchymal Stem Cell-derived Small Extracellular Vesicles Eye Drops
- ClinicalTrials.gov ID
- NCT07623382
- Acronym / sponsor ID
- FirstAHXiamenU
- Conditions
- Dry Eye Disease, Umbilical Cord Mesenchymal Stem Cell-derived Small Extracellular Vesicles
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 3 Jun 2026 (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 clinical trial aims to preliminarily evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell small extracellular vesicle eye drops in patients with dry eye disease.
- Human mesenchymal stem cell small extracellular vesicle eye drops: Administer one drop each time, 4 times daily, for a treatment duration of 4 weeks.
- During treatment, subjects will be followed up and undergo examinations and related tests weekly.
- After completion of treatment, follow-up visits will be conducted every 2 weeks for a total of 2 visits.
- Subsequently, subjects will enter a long-term follow-up period, with follow-up assessments at 3 months and 6 months to observe longer-term safety and efficacy.
- Subjects shall record medication usage and any possible adverse reactions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study employs a self-controlled design . Specifically, there will be a single treatment group, and participants will serve as their own controls by comparing pre- and post-enrollment data
| Arm | Type | Receives |
|---|---|---|
| Using Human mesenchymal stem cell small extracellular Vesicles to treat dry eye | Experimental | Biological: Human umbilical cord mesenchymal stem cell-derived small extracellular vesicle (sEV) eye drops. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects who voluntarily participate and sign the informed consent form, are willing to comply with the treatment schedule specified in the study protocol, and attend follow-up visits on time.
- Aged ≥ 18 years, with no gender restriction.
- Best-corrected visual acuity (BCVA) of both eyes (OU) ≥ 0.1 at the Screening Visit (Visit 1, V1).
- History of dry eye disease in both eyes prior to the Screening Visit (Visit 1, V1), with at least one of the following subjective symptoms: ocular dryness, foreign body sensation, burning sensation, eye fatigue, discomfort, redness, or fluctuating visual acuity.
- Meeting one of the following criteria at the Screening Visit (Visit 1, V1):
Key exclusion criteria (24 listed)
- Subjects with current ocular herpes or any other ocular infection or inflammation, or a history of ocular herpes or any other ocular infection within 30 days prior to screening.
- Subjects with ocular diseases including structural abnormalities of the eyelid margin (ectropion, entropion, eyelid laxity, etc.), severe conjunctivochalasis, Salzmann nodular corneal degeneration, damaged conjunctival goblet cells (e.g., vitamin A deficiency), progressive pterygium, wet age-related macular degeneration (wAMD), glaucoma, diabetic retinopathy, retinal vein occlusion, etc., which, in the investigator's opinion, may increase subject risk or interfere with study outcomes.
- Subjects with secondary ocular scarring that, in the investigator's assessment, may affect subject compliance or outcome evaluation (e.g., radiation scars, chemical burns, Stevens-Johnson syndrome, cicatricial pemphigoid, etc.).
- Subjects with secondary Sjögren's syndrome or other autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.), unless the subject meets all of the following conditions:
- Subjects with a history of organ or bone marrow transplantation.
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 |
|---|---|---|
| Human umbilical cord mesenchymal stem cell-derived small extracellular vesicle (sEV) eye drops.Product: Human umbilical cord mesenchymal stem cell-derived small extracellular vesicle (sEV) eye drops. Dosage Form: Sterile ophthalmic solution. Dosing Regimen: Instill one drop into the affected eye(s) four times daily for a treatment duration of 4 weeks. Administration Route: Topical ocular instillation. Follow-up Schedule: Weekly follow-up during the 4-week treatment period. Post-treatment follow-up at Week 6 and Week 8 (every 2 weeks for 2 visits). Long-term follow-up at Month 3 and Month 6 to evaluate sustained safety and efficacy. | Biological | Using Human mesenchymal stem cell small extracellular Vesicles to treat dry eye |
Primary outcome
Total Corneal Fluorescein Staining Score (TCSS)
Time frame: 4 Weeks
To Evaluate Changes in the Total Corneal Fluorescein Staining Score (TCSS) in Subjects
Tear Film Break-up Time (TBUT)
Time frame: 4 Weeks
To Observe Changes in Tear Film Break-up Time (TBUT) in Subjects
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 3 Jun 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Human umbilical cord mesenchymal stem cell-derived small extracellular vesicle (sEV) eye drops. in people with Dry Eye Disease and Umbilical Cord Mesenchymal Stem Cell-derived Small Extracellular Vesicles, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
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 24 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: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Corneal Fluorescein Staining Score (TCSS) (time frame: 4 Weeks). The study lists 2 primary outcomes in all. 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 3 Jun 2026.