SAFETY AND EFFICACY OF STEM CELL FORTIFIED EYE DROPS IN CORNEAL ULCER TREATMENT

P., Saif,; M., Saif,; W., Amoako,; Sh., Amer,; A., Abdelkarim,; A., Saif,; W., Mahran,

doi:10.21608/ejco.2025.443639

SAFETY AND EFFICACY OF STEM CELL FORTIFIED EYE DROPS IN CORNEAL ULCER TREATMENT

Document Type : Original articles: include clinical trials, interventional research, Basic researches and clinically relevant laboratory investigations

Authors

¹ Ophthalmology dept., Misr Univ. for Science and Technology, 6th October, Egypt,

² Ophthalmology dept., Beni-Suef Univ., Beni-Suef, Egypt, Niles Institute of Longevity Elder Sciences, Beni-Suef Univ., Beni-Suef, Egypt,

³ European Wellness Academy, Kota Kinabalu – Malaysia,

⁴ British Center for Regenerative Medicine, Cairo, Egypt,

⁵ British Center for Regenerative Medicine, Cairo, Egypt, ACE Cells Lab, UK,

⁶ Ophthalmology dept., Fayoum Univ., Fayoum, Egypt

⁷ Ophthalmology dept., Beni-Suef Univ., Beni-Suef, Egypt,

10.21608/ejco.2025.443639

Abstract

Purpose: To evaluate the therapeutic efficacy of stem cell-derived Fortified Drops (ACE Orbit™) in managing persistent and regular corneal ulcers unresponsive to conventional treatment. Methods: This prospective, interventional study included 33 eyes—10 with persistent ulcers (>2 weeks) and 23 with regular ulcers (<2 weeks)—treated with bioactive peptide-based Fortified Drops thrice daily for 30 days. Clinical assessments included epithelial closure, visual acuity, corneal clarity via OCT, pachymetry, and levels of inflammatory biomarkers (MMP-9 and IL-1β). Results: Complete epithelial healing occurred in 80% of persistent ulcers and 100% of regular ulcers (p= 0.009). Group 2 exhibited significantly better outcomes in corneal clarity (p < 0.001), faster healing (15.2 ± 3.2 vs. 22.5 ± 4.5 days, p < 0.001), and greater reductions in MMP-9 and IL-1β levels (p= 0.045 and p=0.027, respectively). Visual acuity and central corneal thickness improved in both groups, though not statistically significantly between them. Mild irritation was the only common adverse effect; one case of perforation occurred in Group 1. Conclusion: Fortified Drops sign-ificantly enhanced corneal healing, reduced inflammation, and improved corneal clarity, particularly in regular ulcers. Although persistent ulcers showed slower and less complete healing, the drops demonstrated promising regenerative potential and a favorable safety profile. These findings support the use of Fortified Drops as a non-invasive, adjunctive treatment for challenging corneal ulcer cases.

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