Does the Act on the Safety of Regenerative Medicine in Japan ensure “safety”?: Implications of low adverse event reporting

再生医療法に基づく再生医療で生じる有害事象の報告状況を調査 --報告件数の少なさは何を意味するのか？. 京都大学プレスリリース. 2023-11-20.Does the Act on the Safety of Regenerative Medicine in Japan ensure “Safety”？ : Implications of low adverse event reporting. 京都大学プレスリリース. 2023-11-20.Public document analysis reveals that the adverse events reported for therapeutic administration under the Act on the Safety of Regenerative Medicine (ASRM) in Japan are substantially fewer than those under the Pharmaceuticals and Medical Devices Act. This study highlights the flawed reporting mechanisms and unmet legislative intentions of the ASRM

Difficulties in ensuring review quality performed by committees under the Act on the Safety of Regenerative Medicine in Japan

自由診療で行われる再生医療の審査に関する課題を調査 今後の制度改正に期待. 京都大学プレスリリース. 2023-02-28.Questionable practices identified by an examination of therapeutic plan reviews performed by certified committees under the Act on the Safety of Regenerative Medicine. 京都大学プレスリリース. 2023-02-28.We outlined five studies regarding the quality of the review by committees based on the Act on the Safety of Regenerative Medicine. The findings raise serious concerns about the independence, integrity, and quality of reviews of therapeutic plans by these committees with inappropriately close relationships to medical institutions and companies

Financial risks posed by unproven cell interventions: Estimation of refunds from medical expense deductions in Japan

自由診療で行われる再生医療がもたらす財政的リスク --日本における医療費控除に基づく還付金額の試算--. 京都大学プレスリリース. 2022-04-25.Financial risks posed by unproven cell interventions in Japan. 京都大学プレスリリース. 2022-04-25

Financial risks posed by unproven cell interventions: Estimation of refunds from medical expense deductions in Japan

Hatta T., Ide K., Fujita M., et al. Financial risks posed by unproven cell interventions: Estimation of refunds from medical expense deductions in Japan. Stem Cell Reports 17, 1016 (2022); https://doi.org/10.1016/j.stemcr.2022.03.015

Science communication in regenerative medicine: Implications for the role of academic society and science policy

It is essential to understand the hurdles, motivation, and other issues affecting scientists' active participation in science communication to bridge the gap between science and society. This study analyzed 1115 responses of Japanese scientists regarding their attitudes toward science communication through a questionnaire focusing on the field of stem cell and regenerative medicine. As a result, we found that scientists face systemic issues such as lack of funding, time, opportunities, and evaluation systems for science communication. At the same time, there is a disparity of attitudes toward media discourse between scientists and the public

Does the Act on the Safety of Regenerative Medicine in Japan ensure “safety”?: Implications of low adverse event reporting

Public document analysis reveals that the adverse events reported for therapeutic administration under the Act on the Safety of Regenerative Medicine (ASRM) in Japan are substantially fewer than those under the Pharmaceuticals and Medical Devices Act. This study highlights the flawed reporting mechanisms and unmet legislative intentions of the ASRM.再生医療法に基づく再生医療で生じる有害事象の報告状況を調査 --報告件数の少なさは何を意味するのか？. 京都大学プレスリリース. 2023-11-20.Does the Act on the Safety of Regenerative Medicine in Japan ensure “Safety”？ : Implications of low adverse event reporting. 京都大学プレスリリース. 2023-11-20