Limbal Stem Cell Deficiency (LSCD) Treatment With Cultivated Stem Cell (CALEC) Graft

Summary

The main aim of the study is to determine the safety and feasibility of a cultivated autologous limbal epithelial cell (CALEC) transplantation in the treatment of limbal stem cell deficiency.

Timeline

Start

2016-08-01

Primary completion

2023-03-31

Completion

2023-03-31

Publications

• Yavuz Saricay L, Kaufman AR, Johns LK, Yin J, Samarakoon L, Ayala AR, Maguire M, Parekh M, Hernandez Rodriguez DE, Daley H, Dana R, Armant M, Ritz J, Jurkunas UV. Central Cornea Changes on Anterior Segment OCT and In Vivo Confocal Microscopy After Autologous Limbal Epithelial Cell Transplantation. Cornea. 2026 Apr 1;45(4):436-442. doi: 10.1097/ICO.0000000000003865. Epub 2025 Mar 28.
• Jurkunas UV, Kaufman AR, Yin J, Ayala A, Maguire M, Samarakoon L, Johns LK, Parekh M, Li S, Gauthier A, Negre H, Shaw KL, Hernandez Rodriguez DE, Daley H, Dana R, Armant M, Ritz J. Cultivated autologous limbal epithelial cell (CALEC) transplantation for limbal tem cell deficiency: a phase I/II clinical trial of the first xenobiotic-free, serum-free, antibiotic-free manufacturing protocol developed in the US. Nat Commun. 2025 Mar 4;16(1):1607. doi: 10.1038/s41467-025-56461-1.

Drugs

Indications