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

NCT07623382 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-06-03

No results posted yet for this study

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. Human mesenchymal stem cell small extracellular vesicle eye drops:

Administer one drop each time, 4 times daily, for a treatment duration of 4 weeks.
2. During treatment, subjects will be followed up and undergo examinations and related tests weekly.
3. After completion of treatment, follow-up visits will be conducted every 2 weeks for a total of 2 visits.
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. Subjects shall record medication usage and any possible adverse reactions.

Conditions

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

Interventions

BIOLOGICAL

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.

Sponsors & Collaborators

  • The First Affiliated Hospital of Xiamen University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2026-11-30
Completion
2026-11-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07623382 on ClinicalTrials.gov