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

Recent Achievements in the Development of Biomaterials Improved with Platelet Concentrates for Soft and Hard Tissue Engineering Applications

“…PRP and its discovery date back to 1970. To date, PRP has been widely used in the treatment of at least ten diseases in more than a hundred thousand patients, and no adverse effects have been reported after its application [17][18][19]. Nevertheless, it was clinically proved that all PCs may delay complications and speed up tissue regeneration.…”

“…• The CHT-SF/Ag/SA/PRP sponge possessed a great ability to absorb liquid and also to keep moisture up to approx. 19 1 PRP-platelet-rich plasma; 2 HSFs-human skin fibroblasts; 3 BMSCs-bone-marrow-derived stem cells; 4 FBS-fetal bovine serum; 5 hUCMSCs-human umbilical-cord-derived mesenchymal stem cells.…”

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

“…The difference in the number of AE reports in the two systems suggests that AEs are inappropriately reported under the ASRM. Arita and Tobita also questioned the absence of AE reports in Japan for platelet-rich plasma (PRP) therapy, which accounts for approximately 66% of RM plans (the most common RM) in Japan, despite several reports of AEs overseas ( Arita and Tobita, 2023 ).…”