Safety and tolerability of topical mesenchymal stromal cell secretome in persistent corneal epithelial disease-a phase 1b clinical trial.
Farshad Abedi, Jeonghyun Esther Kwon, Iskra Araujo et al.
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In 30 seconds
This phase 1b clinical trial evaluated the safety and tolerability of topical allogeneic bone marrow-derived mesenchymal stromal cell secretome in patients with persistent corneal epithelial disease. Nine participants were treated with varying dosing frequencies over 28 days. The study found that the secretome was safe and well tolerated at doses of 2 or 4 times daily, with no dose-limiting toxicities observed in these groups.
Key findings
- No dose-limiting toxicities were observed in 6 patients receiving the secretome 2 or 4 times a day.
- Two of the 3 participants treated 6 times a day developed reversible dose-limiting toxicities.
- Potential signals of clinical efficacy were noted in best-corrected visual acuity and corneal sensation.
Why it matters
Understanding the safety profile of new treatments for persistent corneal epithelial disease is crucial for clinicians. This study suggests that topical BM-MSC secretome may be a viable option, potentially improving patient outcomes without significant adverse effects.