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NOT YET RECRUITING
NCT07902687
PHASE1

A Clinical Study to Evaluate the Safety and Effectiveness of MSCohi-O Lens in the Treatment of Immune-related Ocular Surface Diseases.

Sponsor: Guangdong ProCapZoom Biosciences Co., Ltd.

View on ClinicalTrials.gov

Summary

Immune-related ocular surface diseases are a kind of non-infectious eye disease pedigree, which is mediated by abnormal immune system function and characterized by ocular surface tissue damage. It mainly covers immune keratitis, immune disease-related dry eye, allergic keratoconjunctivitis, Thygeson superficial punctate keratitis, mucosal pemphigoid-related ocular surface damage and other clinical types, and its incidence is closely related to autoimmune disorder, abnormal immune response after infection, genetic susceptibility and environmental triggering factors. At present, there are still obvious therapeutic limitations in clinical routine treatment for immune-related ocular surface diseases. The first-line treatment plan mainly focuses on local glucocorticoid and non-steroidal anti-inflammatory drugs to inhibit inflammatory reaction. Although it can quickly control corneal edema and infiltration in acute stage, there are serious adverse reactions such as elevated intraocular pressure, cataract and corneal thinning and perforation after long-term use, which cannot meet the needs of long-term maintenance treatment. Umbilical cord mesenchymal stem cells (UCMSC) have unique immunomodulatory characteristics in inflammatory environment. Its mechanism of action is mainly to inhibit the over-activation of immune cells and reduce the content of pro-inflammatory factors by secreting soluble cytokines and regulating the release of various anti-inflammatory factors. However, under the traditional medication mode, UCMSC can not stay on the ocular surface. Our company has developed a medicine, namely MSCohi-O lens, which uses soft hydrophilic contact lens to load UCMSC, so as to realize long-term local administration on the ocular surface, make UCMSC play an immunomodulatory role locally, inhibit the over-activation of immune/inflammatory reaction, and finally treat or alleviate the symptoms of immune-related ocular surface diseases. This clinical study is expected to explore the clinical effect of MSCohi-O lens in the treatment of immune-related ocular surface diseases, and initially determine the clinical application of MSCohi-O lens in the treatment of immune-related ocular surface diseases, so as to provide new clinical schemes and treatment ideas for the treatment of immune-related ocular surface diseases.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-11-01

Completion Date

2028-11-30

Last Updated

2026-10-29

Healthy Volunteers

No

Interventions

DRUG

MSCohi-O lens

Each subject chooses one eye as the research eye (if both eyes are consistent, the one with higher corneal fluorescein staining score is preferred, and the eye with poor vision is selected when the score is consistent). The time of wearing glasses is 10 hours a day, wearing them at 08:00 am and taking them off at 18:00 pm.