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Your search keyword '"Yamato, Masayuki"' showing total 46 results
Start Over Author "Yamato, Masayuki" Journal regenerative therapy
46 results on '"Yamato, Masayuki"'

30. How to prevent contamination with Candida albicans during the fabrication of transplantable oral mucosal epithelial cell sheets

Author

Takagi, Ryo, Kobayashi, Shinichiro, Yamato, Masayuki, Owaki, Toshiyuki, Kasai, Yoshiyuki, Hosoi, Takahiro, Sakai, Yusuke, Kanetaka, Kengo, Minamizato, Tokutaro, Minematsu, Asuka, Kondo, Makoto, Kanai, Nobuo, Yamaguchi, Naoyuki, Nagai, Kazuhiro, Miyazaki, Yasushi, Takeda, Naoya, Fukai, Fumio, Asahina, Izumi, Miyazaki, Taiga, Kohno, Shigeru, Yamamoto, Masakazu, Nakao, Kazuhiko, Eguchi, Susumu, and Okano, Teruo

Published
2015
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45. Explant culture of oral mucosal epithelial cells for fabricating transplantable epithelial cell sheet.

Author

Morino T, Takagi R, Yamamoto K, Kojima H, and Yamato M

Abstract

Introduction: Carrier-free autologous mucosal epithelial cell sheets have been clinically utilized as a cell therapy for various epithelial disorders. Fabrication of a transplantable oral mucosal epithelial cell sheet without mouse feeder layers requires a higher seeding density than that of a sheet with mouse feeder layer culture; therefore, a large amount of donor mucosal tissue is needed. However, cell grafts co-cultured with mouse feeder layers are classified by the US Food and Drug Administration (FDA) as xenogeneic products. The goal of this study was to evaluate the utility of oral mucosal epithelial cells expanded by primary explant culture for the fabrication of an adequate number of transplantable epithelial cell sheets without mouse feeder layers., Methods: Small fragments derived from minced oral mucosal tissue were placed into culture dishes for primary explant culture in keratinocyte culture medium. After primary explant culture, the outgrown cells were treated with trypsin-EDTA and were seeded on a temperature-responsive cell culture insert. After subculture, the cultured cells were harvested as a confluent cell sheet from the culture vessel by temperature reduction., Results: Carrier-free human oral mucosal epithelial cell sheets were fabricated in all human cases, and autologous transplantation of the harvested cell sheets showed rapid epithelial regeneration to cover epithelial defects in a rabbit model. The explant culture method, involving the use of small fragments for primary culture, was sufficient for preparing a large number of mucosal epithelial cells without mouse feeder layers. Moreover, oral mucosal epithelial cells derived from the primary explant culture after cryopreservation allowed for the fabrication of cell sheets., Conclusions: This method for fabricating transplantable oral mucosal epithelial cell sheets is an attractive technique for regenerative medicine. It offers a patient-friendly manufacturing method in which a small amount of biopsy material from the patient represents a sufficient epithelial cell source, and a manufacturing plan for preparing cell grafts can be easily tailored.

Published
2018
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46. Regulatory approval for autologous human cells and tissue products in the United States, the European Union, and Japan.

Author

Yano K, Watanabe N, Tsuyuki K, Ikawa T, Kasanuki H, and Yamato M

Abstract

Human cells and tissue products belong to a relatively new class of medical products. Therefore, limited information is available on the classification and premarket evaluation of human cells and tissue products in the United States (US), the European Union (EU), and Japan. In this study, the definition, legislation, and approval system of these products were surveyed. A total of nine autologous human cells and tissue products approved until October 2013 were collected. The definitions of human cells and tissue products were compatible among the US, the EU and Japan. The products were classified as human cells, tissue, and cellular and tissue-based products (HCT/Ps) in the US, advanced therapy medicinal products (ATMPs) in the EU, and cell/tissue-engineered products in Japan. These products were categorized as biologics and medical device in the US and Japan, and drug in the EU. The issuance of new guidance induced regulatory impact for manufacturer, especially in the US. These products are subjected to the accelerated approval of biological product, the humanitarian device exemption approval, the premarket application approval, the biologics license application approval, and new drug application approval with specific targeting of postapproval registry or surveillance. Of nine autologous human cells and tissue products, four products had been evaluated using clinical experiences or open clinical trials with small subjects, although the rests of products had been evaluated using comparative clinical trials with control treatment. Our survey suggests that autologous human cells and tissue products would need postmarket-oriented evaluation rather than premarket-oriented evaluation for doctors and patients., (© 2014 the Japanese Society for Regenerative Medicine. Production and hosting by Elsevier B.V. All rights reserved.)

Published
2014
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