Medical Policy Division Notice No. 0117-1 / Infectious Disease Control Division Notice No. 0117-7
Date: January 17, 2025
From:
Director, Research and Development Policy Division, Health Policy Bureau, Ministry of Health, Labour and Welfare
Director, Infectious Disease Control Division, Department of Health and Sanitation, Ministry of Health, Labour and Welfare
(Official seal omitted)
In light of the recent developments where clinical research involving this technology is being conducted internationally, and considering the likelihood that xenotransplantation may reach the stage of clinical research in Japan as well, the following revisions have been made:
The previous guideline titled “Guidelines on Public Health Issues Related to Infectious Diseases Associated with Xenotransplantation” (Fiscal Year 2015, MHLW Special Research Project Grant, Principal Investigator: Dr. Tetsuo Matano, Director, AIDS Research Center, National Institute of Infectious Diseases) has been revised.
It is now updated as the “Guideline on Risk Management of Xenogeneic Graft-Derived Infectious Diseases Associated with Xenotransplantation” (Fiscal Year 2023, MHLW Special Research Project Grant, Principal Investigator: Dr. Teruhide Yamaguchi, Institute of Biomedical Engineering for Aging, Kanazawa Institute of Technology), as shown in the attached document.
Furthermore, the procedures and requirements for risk management when conducting research or providing treatment involving xenotransplantation under the Act on the Safety of Regenerative Medicine, etc. (Act No. 85 of 2013; hereinafter referred to as "the Act") have been summarized in the attached appendix.
Accordingly, when performing xenotransplantation under the Act, please ensure that the medical and related institutions under your jurisdiction are informed of this notice and that the necessary procedures in accordance with the Act are properly followed.
With the issuance of this notification, the following prior documents are hereby repealed:
“Guidelines on Public Health Issues Related to Infectious Diseases Associated with Xenotransplantation”
(Medical Policy Division Notice No. 0709001, dated July 9, 2002)
“Revision of the Guidelines on Public Health Issues Related to Infectious Diseases Associated with Xenotransplantation”
(Medical Policy Division Notice No. 0613-1, dated June 13, 2016)
“Guideline Based on the Above Regarding the Use of 3T3-J2 and 3T3-NIH Cell Lines as Feeder Cells for Epithelial Regenerative Medicine”
(Medical Policy Division Notice No. 0702001, dated July 2, 2004)
When xenogeneic grafts are temporarily stored through pre-transplant culture, active screening tests, including identification of viruses and mycoplasma, must be conducted to confirm that a sterile state is maintained.
If contamination by pathogens is suspected and such suspicion cannot be ruled out, the graft must not be used for transplantation.