UnknownPhase 1/2

Effect of UMSCs Derived Exosomes on Dry Eye in Patients With cGVHD

China27 participantsStarted 2020-02-21

Plain-language summary

The purpose of this study is to determine whether Umbilical Mesenchymal Stem Cells (UMSCs) derived Exosomes could alleviate dry eye symptoms in patients with chronic Graft Versus Host Diseases (cGVHD).

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. have the following symptoms in at least one eye: dryness, burning sensation, foreign body sensation, discomfort in the ocular surface or visual fatigue;
✓. tear secretion test (Schirmer's Test) of either eye ≤ 10 mm / 5 min;
✓. the corneal fluorescein staining score (CFS) was more than 4;
✓. Tear break time (TBUT) is less than 10 seconds.

Exclusion criteria

✕. Those who are allergic to any component of the drug in this study;
✕. Pregnant or nursing women;
✕. Patients with active fungal, bacterial or viral keratitis or conjunctivitis;
✕. have serious heart, lung, liver or kidney diseases;
✕. Other incurable ocular diseases before the study; such as glaucoma, uveitis, retinitis pigmentosa.
✕. Wearing contact lenses and unwilling to take off in the study;
✕. Performed ocular surgery (including cataract surgery) in recent three months;
✕. Enrolled in other interventional clinical studies at the same time;

What they're measuring

Changes in Ocular Surface Disease Index (OSDI) Score

Timeframe: 3 days, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks

Trial details

NCT IDNCT04213248

SponsorZhongshan Ophthalmic Center, Sun Yat-sen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-18

Contact for this trial

Tian Zhou

(020)66615460 zhoutian@gzzoc.com

View on ClinicalTrials.gov More Dry Eye trials