Human Umbilical Cord Mesenchymal Stem Cell-derived Small Extracellular Vesicles for the Treatment of Dry Eye Disease
Clinical Study on the Treatment of Dry Eye With Human Umbilical Cord Mesenchymal Stem Cell-derived Small Extracellular Vesicles Eye Drops
The First Affiliated Hospital of Xiamen University
20 participants
Mar 31, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
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.
Locations(1)
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NCT07623382