Current status of platelet-rich plasma therapy under the act on the safety of regenerative medicine in Japan

Abstract

In Japan, a legal framework has been established for the safe and effective application of regenerative medicine. After eight years of the Act on the Safety of Regenerative Medicine (RM Act), discussions have been underway in the Ministry of Health, Labor and Welfare of Japan to revise the law owing to numerous novel technologies and inappropriate case reports not anticipated when the law was enacted. Therefore, in this review article, we have reviewed the regenerative medicine provision plans and the contribution of platelet-rich plasma (PRP) therapy, a regenerative medicine technique widely used in Japan post RM Act implementation, to these plans. As of January 2022, 97.2% of the regenerative medicine provided under the RM Act had been for private practice, and most of them were Class Ⅲ regenerative medicine. Notably, PRP was the most used processed cell under the RM Act. PRP therapy accounted for approximately 66% of the regenerative medicine provision plans in clinical research or private practice and was the most provided regenerative medicine technology in Japan. PRP therapy was primarily used in dentistry to regenerate periodontal tissue (approximately 50%), followed by orthopedics, where it is used to treat osteoarthritis. We suggest that further discussion is essential to determine the factors that should be addressed by the RM act to evaluate the efficacy and safety of PRP therapy.

Keywords: Dental; Orthopedic; Platelet-rich plasma; Regenerative medicine; The Act on the Safety of Regenerative Medicine.

Fig. 1

Institutional framework for promoting the future implementation of regenerative medicine [2].

Fig. 2

Current status of regenerative medicine provision plans under the RM Act in Japan. a, Annual transition of the number of regenerative medicine provision plans on research. b, Annual transition of the number of regenerative medicine provision plans on private practice. c, Ratio of the number of plans by type to the total number of provision plans as of November 2021. d, Ratio of research and private practice in each class of provision plans as of November 2021.

Fig. 3

Types of specific processed cells used in regenerative medicine under the RM act in Japan. We used the information on the regenerative medicine provision plans published by the Ministry of Health, Labor and Welfare as of Jan 2022. a, c, e, types of specific processed cells for regenerative medicine in clinical research. b, d, f, types of specific processed cells for regenerative medicine in private practice. PRP, platelet-rich plasma. ASCs, adipose-derived stem cells. BMSCs, bone marrow-derived stem cells.

Fig. 4

Types of diseases targeted by regenerative medicine in private practice under the RM act in Japan. We used the information on the regenerative medicine provision plans published by the Ministry of Health, Labor and Welfare as of Jan 2022. a, c, e, target disease of regenerative medicine on clinical research. b, d, f, Target disease of regenerative medicine in private practice. DM, diabetes mellitus.

Fig. 5

Purpose of using PRP in clinical research and private practice under the RM act in Japan. We used the information on the regenerative medicine provision plans published by the Ministry of Health, Labor and Welfare as of Jan 2022. a, class Ⅱ, research. b, class Ⅱ, private practice. c, class Ⅲ, research. d, class Ⅲ, private practice.