June 11, 2021
Japan Tissue Engineering Co., Ltd.

Marketing approval obtained for
Autologous Cultured Oral Mucosal Epithelium “Ocural”— World’s first regenerative medical product using oral mucosal epithelial cells
for the treatment of limbal stem cell deficiency —Japan Tissue Engineering Co., Ltd. (“J-TEC”, headquarters in Gamagori, Aichi, Japan; President& CEO Ken-ichiro Hata) is pleased to announce that marketing approval was obtained for
Autologous Cultured Oral Mucosal Epithelium “Ocural” on June 11, 2021.
“Ocural” is a product for the treatment of limbal stem cell deficiency, *1 and it is the world’s firstregenerative medical product using oral mucosal epithelial cells to treat this disease. This productwill be manufactured in Japan and was developed through the practical application of technology
developed by Prof. Kohji Nishida of the Department of Ophthalmology, Osaka University Graduate
School of Medicine. It will be Japan’s second regenerative medical product in the ophthalmology
field, following Autologous Cultured Corneal Epithelium “Nepic”,*2 for which marketing approval wasobtained in March 2020.
“Ocural”, the product for which marketing approval was obtained this time, is a sheet of epithelial
cells derived from human (autologous) oral mucosa that is manufactured by harvesting the patient’sown oral mucosal tissue and culturing the cells isolated from it. The purpose of the product is torepair damaged corneal epithelium, and when this product is transplanted onto the surface of thepatient’s eyes, the patient’s own oral mucosal epithelial cells become engrafted and epithelialize.
“Ocural” is a promising new treatment method for patients who have extensive damage to thecornea of both eyes from limbal stem cell deficiency and have markedly reduced visual acuity.
“Ocural” was designated a regenerative medical product for the treatment of rare diseases *3 in 2020,
with the indication of limbal stem cell deficiency.
As the top runner in regenerative medicine in Japan, J-TEC obtained marketing approval for
Autologous Cultured Epidermis “JACE”, which became Japan’s first regenerative medical product, in2007, and began marketing it in 2009. J-TEC went on to obtain marketing approval for Autologous
Cultured Cartilage “JACC” in 2013 and Autologous Cultured Corneal Epithelium “Nepic” in March of2020. “JACC” and “Nepic” were Japan’s first regenerative medical products in the orthopedic
surgery and ophthalmology fields, respectively.
Through the practical application of “Ocural” in addition to “Nepic”, J-TEC has made it possible toprovide therapies for corneal epithelial diseases, for which curative treatment methods previously
did not exist. J-Tec is promoting the industrialization of regenerative medicine and contributing to theimprovement of patients’ quality of life (QOL) by further strengthening sales of its existing productsand accelerating the development of new regenerative medical products.

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

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1.

Summary
The following is a summary of the marketing approval.
Approval number

30300FZX00003000

Approval dateJune 11, 2021

Nonproprietary name

Human (Autologous) Oral Mucosal Epithelial Cell Sheet

Brand name

OcuralIndications, effects, orLimbal stem cell deficiency
performance1.

Approval conditions

2.

3.

The MAF must take the necessary measures, such as widely disseminating
proper use guidelines prepared in cooperation with the related learned
societies and providing training to physicians, to ensure that this product isused only by physicians (a) who have sufficient knowledge of and experience
with limbal stem cell deficiency, (b) have acquired a sufficient knowledge of theskills involved in the method of use, and of the potential complications
associated with use of the procedure, and (c) will use the product in compliancewith the “Indications, effects, or performance” and “Dosage and administrationof method of use”, at a medical institution that is equipped to handle thetreatment of limbic stem cell deficiency.
Because the number of clinical trial cases is extremely limited, the MAF should,
as a general rule, strive to grasp background information on the patients using
this product and collect data on the safety and efficacy of this product early on
by conducting surveys of the results of use in all cases, and also take thenecessary measures to ensure proper use of this product, until the end of thereexamination period.
In light of the risks associated with heterologous transplantation of the 3T3-J2cells derived from mouse embryos that are used as feeder cells in themanufacturing process for this product, the MAF must take the necessary
measures to ensure proper handling, such as retaining samples of the final
products and records related to use for 30 years.

2. History
In the development of this product, an investigator-initiated clinical trial was conducted by Prof.
Kohji Nishida and Lecturer Yoshinori Oie et al of Osaka University Graduate School of Medicine(Department of Ophthalmology) with support from AMED.*4 J-TEC introduced the autologous
cultured oral mucosal epithelial cell sheet transplantation technology that Dr. Kohji Nishida led theworld in developing, and took over the investigator-initiated clinical trial, conducting it as a corporatesponsored clinical trial of “Ocural” since September of 2016. In September of 2020, J-TEC submitted
a marketing approval application to the Ministry of Health, Labour and Welfare for “Ocural” as thesecond regenerative medical product in the ophthalmology field. “Ocural” is to be marketed byophthalmological medical device maker Nidek Co., Ltd. (Gamagori, Aichi; President and CEOMotoki Ozawa).

*1*2*3*4A disease in which corneal epithelial stem cells, which exist in the corneal limbus at the border between the cornea and theconjunctiva, 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 andWelfare in accordance with the Pharmaceuticals and Medical Devices Law. Products with this designation receive preferentialtreatment, such as grants for research, priority clinical trial consultation and review, and extension of the reexamination period. Inorder 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 safety that 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 the form of sheetsthat are transplanted back into the patient’s eyes to reconstruct the corneal epithelium. NEPIC was included in the National Health
Insurance price list in June of 2020, and it is marketed by Nidec Co., Ltd.
Japan Agency for Medical Research and Development

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

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Transplantation of autologous cultured oral mucosal epithelium “Ocural”

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
E-mail: 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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