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Ula V. Jurkunas; Cultivated Autologous Limbal Epithelial Cell (CALEC) Transplantation: New Frontier in the Treatment of Limbal Stem Cell Deficiency. Invest. Ophthalmol. Vis. Sci. 2018;59(9):3904.
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Presentation Description :
Our study is a collaborative research project that is based on translational innovation and has a high potential for impacting patient care. Corneal transplantation with cultivated autologous limbal epithelial (stem) cells (CALEC) is technology aimed at restoring vision for patients whose cornea has been compromised by limbal stem cell deficiency (LSCD). During product and process development, we have established a consistent manufacturing process using only qualified and validated reagent and defined standardized clinical end-points required for adoption of this methodology in the clinical practice. We have assembled a unique team with cutting-edge expertise in stem cell biology, formulation of GMP-compatible cell products, clinical expertise, and clinical trial development by forging a partnership between Harvard Department of Ophthalmology, the Connell O'Reilly Cell Manipulation Core Facility at the Dana-Farber Cancer Institute, the Jaeb Center, and the National Institute of Health. We have received Investigational New Drug Application (IND #16102) approval from the FDA to perform a clinical trial on the CALEC transplantation at the Massachusetts Eye and Ear, Boston. This is a single- center study to assess safety and feasibility of CALEC grafts and to compare their efficacy to the Conjunctival Limbal Autografts (CLAU) in 24 patients with unilateral LSCD. By performing the first ex vivo stem cell transplantation in the U.S., this study will pave the way for development of cell manufacturing technology based on rigorously vetted processes and will bring the novelty of a well-controlled stem cell-based clinical trial to the forefront of regenerative medicine.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.
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