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Establishment of a keratinocyte and fibroblast bank for clinical applications in Japan

Abstract

Regenerative medicine products using allogeneic cells, such as allogeneic cultured epidermis (allo-CE), have become a more critical therapeutic method for the treatment of burns. However, there are no clinically available allo-CE products in Japan. Therefore, establishing a quality-controlled cell bank is mandatory to create regenerative medical products using allogeneic cells. In this study, we selected ten patients from the Department of Plastic Surgery of Kyoto University Hospital to become cell donors. We performed medical interviews and blood sampling for the donor to ensure virus safety. We examined the tissues and isolated cells by performing a nucleic acid test (NAT). To establish a master cell bank, quality evaluation was performed according to the International Conference of Harmonization (ICH) Q5A. Serological tests of the blood samples from the ten donors showed that two of them were ineligible. The cells registered in the cell bank were found to be compatible after virus testing was performed, and a master cell bank was constructed. Hence, we established a keratinocyte and fibroblast bank of clinically usable human cultured cells in Japan for the first time.

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Acknowledgements

The authors would like to thank Rie Tatsumi, Minako Chaya, and Yasuko Minaki for their generous assistance.

Funding

This research was supported by the Japan Agency for Medical Research and Development (AMED) under Grant Number JP17be0104005.

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Correspondence to Yasuhiro Katayama.

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Our study was approved by the Ethics Committee at our institute (No. R0690).

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Nakano, T., Katayama, Y., Sakamoto, M. et al. Establishment of a keratinocyte and fibroblast bank for clinical applications in Japan. J Artif Organs (2022). https://doi.org/10.1007/s10047-022-01331-6

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  • DOI: https://doi.org/10.1007/s10047-022-01331-6

Keywords

  • Allogeneic cultured epidermis
  • Cell bank
  • Clinical application
  • Regenerative medicine
  • Virus tests