NEWS

The Japanese Society for Regenerative Medicine (JSRM) is pleased to announce the publication of the English version of the “Basic Points to Consider for Cell Storage under the Act on the Safety of Regenerative Medicine” (hereinafter referred to as “the Guideline”).
In regenerative medicine and cell therapies (RMTs) conducted under the Act on the Safety of Regenerative Medicine (RM Safety Act), the quality of processed cells directly affects the safety and effectiveness of RMTs. In response to this, the JSRM, supported by the Japan Agency for Medical Research and Development (AMED) through the Project to Promote the Foundation for Practical Application of Regenerative Medicine (research and development program: Complement and Management of National Consortium for Regenerative Medicine), established the “Task Force responsible for drafting the Basic Points to Consider for Cell Storage under the Act on the Safety of Regenerative Medicine” On April 15, 2024, the Task Force published the Japanese version of the Guideline summarizing fundamental concepts that RMT practitioners and institutions that provide cell storage should take into account.
To promote international understanding and discussion, we have now released the English version of the Guideline. In conjunction with this, a review article explaining the development process and the scientific and regulatory significance of the Guideline has been published in the international journal “Regenerative Therapy”. We encourage all stakeholders to read the Guideline and hope that it will contribute to the appropriate implementation of cell storage. The content will continue to be updated as needed, and we welcome any feedback or suggestions.

■ English Version of the Guideline (URL to be inserted)
https://www.jsrm.jp/activity/regulatoryaffairs/#a04

■ Review Article

• Title: “Basic Points to Consider for Cell Storage under the Act on the Safety of Regenerative Medicine in Japan”
• Journal: Regenerative Therapy (Volume 30, December 2025, Pages 252-258)
• https://doi.org/10.1016/j.reth.2025.06.011

■ Task Force Members

• Chair: Masahiro Kino-oka, Ph.D. (Graduate School of Engineering, The University of Osaka)
• Members (in Japanese alphabetical order):
• Yuki Uno, M.S. (Graduate School of Engineering, The University of Osaka)
• Kosuke Kawai, B.A. (Iwatani Corporation / Forum for Innovative Regenerative Medicine)
• Morikuni Tobita, D.D.S., Ph.D. (Medical Technology Innovation Center, Juntendo University)
• Kazuaki Nakamura, Ph.D. (National Center for Child Health and Development)
• Manabu Mizutani, Ph.D. (Graduate School of Engineering, The University of Osaka)
• Masatoki Watanabe (Japan Tissue Engineering Co., Ltd.)

For more information, please contact:
Human Resource Development Unit,
Japanese Society for Regenerative Medicine
Email: hrd@jsrm.jp