Japanese Laws and the Current Status of Regenerative Medicine in the Tohoku Region

Yuya Kamano; Noboru Terajima; Yuta Chiba; Venkata V Suresh; Masahiro Saito

doi:10.5005/jp-journals-10024-3487

Japanese Laws and the Current Status of Regenerative Medicine in the Tohoku Region

J Contemp Dent Pract. 2023 Feb 1;24(2):120-128. doi: 10.5005/jp-journals-10024-3487.

Authors

Yuya Kamano¹, Noboru Terajima², Yuta Chiba², Venkata V Suresh³, Masahiro Saito³

Affiliations

¹ Tohoku Health and Welfare Bureau, Ministry of Health, Labour and Welfare, 1-1-20 Kakyoin, Aoba-ku, Sendai, Miyagi, 981-0952, Japan, Phone: +81 227269263, e-mail: kamano-yuuya.3t9@mhlw.go.jp.
² Tohoku Health and Welfare Bureau, Ministry of Health, Labour and Welfare, 1-1-20 Kakyoin, Aoba-ku, Sendai, Miyagi, 981-0952, Japan.
³ Division of Operative Dentistry, Department of Ecological Dentistry, Graduate School of Dentistry, Tohoku University, 4-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan.

PMID: 37272144
DOI: 10.5005/jp-journals-10024-3487

Abstract

Aim: The aim of this study was to review Japanese laws regarding regenerative medicine and the current status of clinical application of regenerative medicine, to learn about the advantages and problems, and to thereby serve as a reference for measures necessary for the development of regenerative medicine.

Background: Regenerative medicine started in 1957 with the transplantation of hematopoietic stem cells, followed by the establishment of embryonic stem cells in 1981 and induced pluripotent stem cells in 2006, and continues to evolve progressively. At the same time, however, problems have emerged due to lax legal regulations, such as the use of treatments that lack scientific evidence.

Review results: The Japanese government enacted two laws to regulate regenerative medicine: the Law to Ensure the Safety of Regenerative Medicine and the Amend the Pharmaceutical Affairs Law in 2013. These laws were enacted with the aim of providing safe regenerative medicine promptly and smoothly and developing many regenerative medicine products. In these laws, regenerative medicine is defined as medical treatment that restores lost functions of damaged organs and tissues with the help of cellular and tissue-based products. Nowadays, there are two major methods of regenerative medicine. One representative method involves the transplantation of devices that activates self-regenerative ability by introducing living cells into patients' body. The other method is the activation and differentiation of endogenous stem cells with cell growth and differentiation factors.

Conclusion: The current status of regenerative medicine in the Tohoku region after the enactment of these laws is described in detail. This clarified the advantages and disadvantages associated with regenerative medicine as it is currently practiced in Japan.

Clinical significance: Development of regenerative medicine in dentistry will be advanced by learning about its clinical application in medicine.

Keywords: Japanese Laws on Regenerative Medicine; Regenerative medicine Tohoku region..

MeSH terms

Humans
Induced Pluripotent Stem Cells*
Japan
Regenerative Medicine* / legislation & jurisprudence