Safety and Efficacy of a Mesenchymal Stem Cell Secretome Therapy (KPI-012) for Persistent Corneal Epithelial Defects: A Phase 1b Trial
The results from this small phase 1b open-label trial suggest that in participants with PCED of multiple etiologic origin, twice daily KPI-012 therapy exhibits a favorable safety profile-efficacy profile and may promote rapid wound healing. The small sample size limits the generalizability of the findings, and thus a later-phase clinical investigation with a larger sample size is warranted to establish the statistically driven therapeutic effect.
Authors
- Alejandro Navas
- Valeria Sánchez-Huerta (ORCID: https://orcid.org/0000-0001-8652-964X)
- Stephen C. Pflugfelder
- Enrique O. Graue-Hernández
- Hugo Quiroz-Mercado
- Spencer Alford
- Darius Kharabi
Institutions
- Baylor College of Medicine (US)
- Kala Pharmaceuticals (United States) (US)
- Asociacion Para Evitar la Ceguera en México Hospital Dr. Luis Sánchez Bulnes (MX)
Publication Details
- Journal
- Current Therapeutic Research
- Published
- 2025-01-01
- DOI
- https://doi.org/10.1016/j.curtheres.2025.100799
- Citations
- 2
- Primary Topic
- Corneal Surgery and Treatments
- Type
- article
- Field-Weighted Citation Impact
- 2.72