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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

Author

Listed:
  • 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
    Harvard Medical School)

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

Suggested Citation

  • 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 , 2025. "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 manufacturin," Nature Communications, Nature, vol. 16(1), pages 1-12, December.
    • Handle: RePEc:nat:natcom:v:16:y:2025:i:1:d:10.1038_s41467-025-56461-1
    DOI: 10.1038/s41467-025-56461-1
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