Human Umbilical Cord Mesenchymal Stem Cell-derived Small Extracellular Vesicles for the Treatment of Dry Eye Disease

NCT07623382 | Recruiting Early Phase 1

• 1 other identifier: FirstAHXiamenU
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 1.Human mesenchymal stem cell small extracellular vesicle eye drops:
2. 2.During treatment, subjects will be followed up and undergo examinations and related tests weekly.
3. 3.After completion of treatment, follow-up visits will be conducted every 2 weeks for a total of 2 visits.
4. 4.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.
5. 5.Subjects shall record medication usage and any possible adverse reactions.

Conditions

Dry Eye Disease; Umbilical Cord Mesenchymal Stem Cell-derived Small Extracellular Vesicles

Outcome Measures

Primary Outcomes (2)

• Total Corneal Fluorescein Staining Score (TCSS)

  To Evaluate Changes in the Total Corneal Fluorescein Staining Score (TCSS) in Subjects

  4 Weeks

• Tear Film Break-up Time (TBUT)

  To Observe Changes in Tear Film Break-up Time (TBUT) in Subjects

  4 Weeks

Study Arms (1)

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.

Interventions

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.

Using Human mesenchymal stem cell small extracellular Vesicles to treat dry eye

Eligibility Criteria

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

You may qualify if:

• 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):
• i. Positive corneal fluorescein staining, TBUT \< 10 s, and OSDI score ≥ 13; ii. Negative corneal fluorescein staining, TBUT \< 5 s, and OSDI score ≥ 13

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

The First Affiliated Hospital of Xiamen University

Xiamen, China, 361000, China

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Design

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

Model Details: 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

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: June 3, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: June 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)