May 24, 2021
Japan Tissue Engineering Co., Ltd.

Reviewed and acknowledged by MHLW subcommittee:
approval of autologous cultured oral mucosal epithelial cell sheet(development code: COMET01)
Japan Tissue Engineering Co., Ltd. (J-TEC; headquarters in Gamagori City, Aichi Prefecture;
President & CEO, Ken-ichiro Hata) is pleased to announce that marketing approval of ourautologous cultured oral mucosal epithelial cell sheet (Development Name: COMET01) for thetreatment of limbal stem cell deficiency (LSCD) *1 has been reviewed and acknowledged at today’smeeting of the Regenerative Medical Products and Biological Technology Subcommittee of theMinistry of Health, Labour and Welfare’s Pharmaceutical Affairs and Food Sanitation Council.
COMET01 is epithelial cell sheet derived from human (autologous) oral mucosa. It is prepared byharvesting oral mucosal tissue from the patient and then cultivating the isolated cells. The purposeof this product is to repair defective corneal epithelium by transplanting the sheet onto the ocularsurface, where the patient’s own oral mucosal epithelial cells become engrafted and epithelialize.
COMET01 is a promising new treatment method for patients who have extensive damage to thecornea of both eyes and markedly reduced visual acuity owing to LSCD.
COMET01 was designated a regenerative medical product for orphan diseases *2 — specificallythe treatment of LSCD — in 2020.
J-TEC introduced the transplantation technique for autologous cultured oral mucosal epithelial cellsheets developed by Professor Kohji Nishida of Graduate School of Medicine/Faculty of Medicine,
Osaka University (Department of Neural and Sensory Organ Surgery (Department ofOphthalmology)) and has taken over the investigator-initiated trial conducted by Professor Nishida’sgroup, conducting it in the form of a company-sponsored clinical trial of COMET01 since Septemberof 2016. In September of 2020, J-TEC submitted an application for marketing approval of COMET01
to the Ministry of Health, Labour and Welfare as Japan’s second regenerative medical product in theophthalmology field.
Marketing of COMET01 is to be conducted by Nidek Co., Ltd. (Gamagori City, Aichi Prefecture;President and CEO, Motoki Ozawa), a maker of ophthalmology and optometry products.
As the top runner in regenerative medicine in Japan, J-TEC obtained marketing approval for
autologous cultured epidermis “JACE”, Japan’s first regenerative medical product, in 2007 andbegan marketing JACE in 2009. Marketing approval was then obtained for autologous cultured
cartilage “JACC” in 2013 and for autologous cultured corneal epithelium “NEPIC” *3 in March of 2020.
JACC was Japan’s first regenerative medical product in the orthopedic surgery field, and NEPIC
was the first in the ophthalmology field.
Through the practical application of first NEPIC and then COMET01, J-TEC has succeeded inproviding a treatment method for corneal epithelial diseases for which no curative therapy previouslyexisted. By reinforcing sales of existing products and accelerating development of new regenerative
medical products, J-TEC is promoting the development of regenerative medicine into an industry
while also contributing to the improvement of patients’ quality of life (QOL).
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A disease in which corneal epithelial stem cells, which exist in the corneal limbus at the border between the cornea
and the conjunctiva, are lost owing to congenital or exogenous factors. LSCD presents with clinical symptoms such as
clouding of the cornea, decline in visual acuity, and eye pain.
Regenerative medical products for the treatment of orphan diseases that are designated by the Minister of Health,Labour and Welfare in accordance with the Pharmaceuticals and Medical Devices Law. Products with this designation
receive preferential treatment, such as grants for research, priority clinical trial consultation and review, and extensionof the reexamination period. In order for a product to be designated a regenerative medical product for orphan
diseases, it must have a target disease that affects fewer than 50,000 patients in Japan and lacks a suitable
alternative treatment method, and the product must have exceptional medical utility value, such as efficacy and safetythat can be expected to greatly surpass those of existing treatment methods.
NEPIC is made by culturing corneal epithelial stem cells harvested from the patient’s own corneal limbic tissue into theform of sheets that are transplanted back into the patient’s eyes to reconstruct the corneal epithelium. NEPIC wasincluded in the National Health Insurance price list in June of 2020, and it is marketed by Nidec Co., Ltd.

Transplantation of autologous cultured oral mucosal epithelium (Development Name: COMET01)
Patient
Harvesting of oral mucosal tissue

Isolation of oral mucosal epithelial cells

Feeder cells: cells used to create thenecessary environment for proliferationof oral mucosal epithelial cells

Seeding of oral mucosal epithelial cells

Feeder cells

Transplantation

Sheet formation

Culturing

Inquiries concerning this topic:
Japan Tissue Engineering Co., Ltd.
Corporate Planning Department, Corporate Management HQ
TEL: 0533-66-2020 Email: jtec-info@jpte.co.jp

Japan Tissue Engineering Co., Ltd., 6-209-1 Miyakitadori, Gamagori, Aichi 443-0022, Japan. URL: https://www.jpte.co.jp

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