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Cultivated oral mucosal epithelial sheet is an autologous, tissue-engineered cell therapy product designed for ocular surface reconstruction in patients with severe limbal stem cell deficiency (LSCD). The therapy involves harvesting a small biopsy of the patient's own oral mucosal tissue, from which epithelial cells are isolated and expanded ex vivo into a multilayered sheet, typically using temperature-responsive culture surfaces or substrates such as amniotic membrane or fibrin gel. This sheet is then surgically transplanted onto the damaged cornea to restore a functional epithelial layer, prevent conjunctivalization, and improve visual acuity. The procedure, known as Cultivated Oral Mucosal Epithelial Transplantation (COMET), is particularly indicated for bilateral LSCD caused by conditions such as Stevens-Johnson syndrome, ocular cicatricial pemphigoid, and severe chemical or thermal burns, where autologous limbal grafts are not feasible. The product Ocular® was the first commercially available COMET product, receiving approval in Japan as a regenerative medicine product.
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