Human Umbilical Cord Mesenchymal Stem Cell-derived Small Extracellular Vesicles for the Treatment… (NCT07623382) | Clinical Trial Compass
RecruitingEarly Phase 1
Human Umbilical Cord Mesenchymal Stem Cell-derived Small Extracellular Vesicles for the Treatment of Dry Eye Disease
China20 participantsStarted 2026-03-31
Plain-language 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
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Not receiving steroids, immunomodulatory, or immunosuppressive agents for the disease;
. The investigator determines that the medical condition will not impact study results.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total Corneal Fluorescein Staining Score (TCSS)
Timeframe: 4 Weeks
2
Tear Film Break-up Time (TBUT)
Timeframe: 4 Weeks
Trial details
NCT IDNCT07623382
SponsorThe First Affiliated Hospital of Xiamen University