Cultivated autologous limbal epithelial cell (CALEC) transplantation for limbal stem cell deficiency: a phase I/II clinical trial of the first xenobiotic-free, serum-free, antibiotic-free manufacturing protocol developed in the US

Ula V. Jurkunas (), Aaron R. Kaufman, Jia Yin, Allison Ayala, Maureen Maguire, Lassana Samarakoon, Lynette K. Johns, Mohit Parekh, Sanming Li, Alex Gauthier, Helene Negre, Kit L. Shaw, Diego E. Hernandez Rodriguez, Heather Daley, Reza Dana, Myriam Armant and Jerome Ritz
Additional contact information
Ula V. Jurkunas: Harvard Medical School
Aaron R. Kaufman: Harvard Medical School
Jia Yin: Harvard Medical School
Allison Ayala: Jaeb Center for Health Research
Maureen Maguire: Jaeb Center for Health Research
Lassana Samarakoon: Jaeb Center for Health Research
Lynette K. Johns: Harvard Medical School
Mohit Parekh: Harvard Medical School
Sanming Li: Harvard Medical School
Alex Gauthier: Harvard Medical School
Helene Negre: Dana-Farber Cancer Institute
Kit L. Shaw: Dana-Farber Cancer Institute
Diego E. Hernandez Rodriguez: Dana-Farber Cancer Institute
Heather Daley: Dana-Farber Cancer Institute
Reza Dana: Harvard Medical School
Myriam Armant: Boston Children’s Hospital
Jerome Ritz: Dana-Farber Cancer Institute

Nature Communications, 2025, vol. 16, issue 1, 1-12

Abstract: Abstract We developed a two-stage manufacturing process utilizing cultivated autologous limbal epithelial cells (CALEC), the first xenobiotic-free, serum-free, antibiotic-free protocol developed in the United States, to treat blindness caused by unilateral limbal stem cell deficiency (LSCD) and conducted a single-center, single-arm, phase I/II clinical trial. Primary outcomes were feasibility (meeting release criteria) and safety (ocular infection, corneal perforation, or graft detachment). Participant eligibility included male or female participants age 18 to

Date: 2025
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DOI: 10.1038/s41467-025-56461-1

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