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Cultivated autologous limbal epithelial cells (CALEC) is an experimental autologous cell therapy developed by Massachusetts Eye and Ear for the treatment of unilateral limbal stem cell deficiency (LSCD). The therapy involves harvesting a small biopsy of limbal stem cells from the patient's healthy contralateral eye, which are then expanded ex vivo using a novel xenobiotic-free, serum-free, and antibiotic-free manufacturing process. These expanded cells are seeded onto a de-epithelialized human amniotic membrane to create a bio-engineered cellular tissue graft. This graft is surgically transplanted onto the damaged cornea to restore the limbal stem cell population and re-establish the ocular surface integrity. Phase I/II clinical trials have demonstrated high success rates in restoring corneal surfaces in patients with chemical or thermal burns.
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