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

• Status: Recruiting
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

Criteria

Inclusion Criteria:

Diagnosed cGVHD with apparent dry eye symptoms by intern specialists and ophthalmologists, and previous application of artificial tears could not relieve the dry eye symptoms.

And meet the following standards:

1. have the following symptoms in at least one eye: dryness, burning sensation, foreign body sensation, discomfort in the ocular surface or visual fatigue;

2. tear secretion test (Schirmer's Test) of either eye ≤ 10 mm / 5 min;

3. the corneal fluorescein staining score (FLCs) was less than 6;

4. Tear break time (TBUT) is less than 10 seconds.

Exclusion Criteria:

1. Those who are allergic to any component of the drug in this study;

2. Pregnant or nursing women;

3. Patients with active fungal, bacterial or viral keratitis or conjunctivitis;

4. have serious heart, lung, liver or kidney diseases;

5. Other incurable ocular diseases before the study; such as glaucoma, uveitis, retinitis pigmentosa.

6. Wearing contact lenses and unwilling to take off in the study;

7. Performed ocular surgery (including cataract surgery) in recent three months;

8. Enrolled in other interventional clinical studies at the same time;

9. Application of eye drops that might affect the clinical study in the past 24 hours;

10. Unable to complete the study according to the investigators' requirements;

11. Serious systemic diseases.