Limbal stem cell deficiency treatments using Autologous Cultured Corneal Epithelium have been covered by insurance since June 1, 2020.
Regenerative medicine for the cornea
If the cornea of the human eye is scratched and some of the corneal epithelium is lost, the injury will rapidly be healed as corneal epithelial cells supplied from the limbus proliferate. However, if a patient sustains burns or gets chemical substances in an eye, there may be extensive loss of the corneal epithelium over an area that includes the limbus, and in this case the conjunctival epithelium accompanied by the blood vessels in the periphery of the limbus will be infiltrated. If this happens, the surface of the cornea becomes covered with conjunctival epithelium, which causes the corneal epithelium to become cloudy, leading to a decline in visual acuity. This condition is called limbal stem cell deficiency (LSCD). The available treatments for LSCD are autologous corneal limbus transplantation, where the transplant is corneal limbus from the patient's own heathy eye, and allogeneic corneal limbus transplantation, where the transplant is corneal limbus from a donor. However, autologous corneal limbus transplantation is a highly invasive, risky procedure because it is necessary to harvest an extensive amount of corneal limbus from the healthy eye (about 30 to 40% of the corneal limbus). Allogeneic corneal limbus transplantation also is fraught with challenges because long-term immunosuppression is necessary and the number of donors is insufficient. In some cases "amnion transplantation" is performed to treat corneal damage. However, while the amnion has the effects of inhibiting inflammation and supporting the growth of cells, it does not contain corneal epithelial stem cells. For this reason, there need to be residual corneal epithelial stem cells in the patient's eye. Thus, an adequate treatment method for LSCD has not existed until now.
The Autologous Cultured Corneal Epithelium made by regenerative medicine is capable of overcoming these challenges. The transplantation procedure consists of harvesting the conjunctival epithelial cells that cover the patient's cornea and culturing them into Autologous Cultured Corneal Epithelium sheets, which are then transplanted back into the patient's eye. When the corneal epithelial stem cells contained in the transplanted Autologous Cultured Corneal Epithelium become engrafted (living cells attach themselves to the surface of the body) and epithelialize, the corneal epithelium will be reconstructed.
The use and commercialization of the medicinal products developed by Japan Tissue Engineering Co., Ltd. that are referred to on this website are approved only in Japan. A potential use and commercialization in other regions will be subject to the prior granting of a marketing authorization in the given territory and compliance with applicable laws.