Human Umbilical Cord Mesenchymal Stem Cell-derived Small Extracellular Vesicles for the Tr
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 treat
| Condition(s) | Dry Eye Disease, Umbilical Cord Mesenchymal Stem Cell-derived Small Extracellular Vesicles |
|---|---|
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: * 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 corne |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | The First Affiliated Hospital of Xiamen University |
| Locations | Xiamen, China, China |
| Start date | 2026-03-31 |
| NCT ID | NCT07623382 |
| Official listing | https://clinicaltrials.gov/study/NCT07623382 |