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

Launched by ZHONGSHAN OPHTHALMIC CENTER, SUN YAT-SEN UNIVERSITY · Dec 25, 2019

Keywords

ClinConnect Summary

Among patients with cGVHD, 60% - 90% are affected by dry eye symptoms, presenting as progressive development of dryness, foreign body sensation, photophobia, pain and even blindness, which seriously affect their life quality. At present, the standard first-line treatment of cGVHD is still hormone or combined with immunosuppressant of cyclosporine. The dry eyes related to cGVHD are treated with artificial tears, lacrimal punctum embolization, local immunosuppressant or even blepharoplasty to reduce dry eye symptoms. Although a variety of new immunosuppressants and monoclonal antibodies have ...

Gender

ALL

Eligibility 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 (CFS) was more than 4;
• • 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.

Trial Officials