Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease
In this phase II randomized double-masked clinical trials, subjects with non-resolving corneal epithelial disease/defect (i.e., refractory to standard treatments for at least two weeks) will receive 8 weeks treatment of topical mesenchymal stem cell secretome or vehicle, with continued follow-up for up to Day 70.
| Condition(s) | Persistent Corneal Epithelial Defect, Corneal Epithelial Disorders |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | In this phase II randomized double-masked clinical trials, subjects with non-resolving corneal epithelial disease/defect (i.e., refractory to standard treatments for at least two weeks) will receive 8 weeks treatment of topical mesenchymal stem cell secretome or vehicle, with continued follow-up for up to Day 70. |
| Who can participate | Inclusion Criteria: * Age ยท Patients 18 years of age or older * Ocular Health * Chronic corneal epithelial disease with fluorescein staining score 6 by NEI grading scale or persistent corneal epithelial defect present for longer than 14 days despite standard treatment * No objective clinical evidence of significant (\> 50%) improvement/worsening of the epithelial disease in the last 14 days * Epithelial disease refractory to conventional non-surgical treatments (e.g., preservative-free artificial tears, gels or ointments; discontinuation of preserved topical drops; anti-inflammatory therapy) * If both eyes of subject meet the inclusion criteria, the eye with the higher fluorescein staining score will be enrolled to the study. * Study Procedures * Only patients who satisfy all Informed Cons |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University of Illinois at Chicago |
| Locations | Chicago, Illinois, United States |
| Start date | 2025-08-01 |
| NCT ID | NCT06919081 |
| Official listing | https://clinicaltrials.gov/study/NCT06919081 |