Comprehensive Quality Control of the Regenerative Therapy Using Platelet Concentrates: The Current Situation and Prospects in Japan.

Platelet concentrates (PCs), represented by platelet-rich plasma (PRP), have been widely applied in the fields of regenerative and aesthetic therapies. PCs' mechanisms of action, however, are too complicated, and it is not easy to present the whole picture; besides, clinical outcomes are hardly reproducible in many cases. Therefore, several medically advanced countries seemingly intend to regulate PC therapies weakly or strictly because of the increasing popularity. Japan established laws and regulations for PC therapy in the "Act on the Safety of Regenerative Medicine" along with the "Pharmaceuticals, Medical Devices and Other Therapeutic Products Act" in 2014, which, to our knowledge, represent the strictest regulatory framework for production and therapeutic use of PCs in the world. According to these laws and regulations, PCs produced for topical use should be prepared as cell-based medicinal products, essentially as should stem cells, in accordance with their registered ("licensed" under actual conditions) standard operating procedures. Nonetheless, criteria for their quality are not standardized. In this review, we discuss the quality of PC preparations by focusing on the basic concept and regulatory framework of regenerative medicine in Japan. Within the new framework, PC therapy is regulated by a specific notification and registration system, as is stem cell therapy. In comparison with the latter, however, risk factors that hamper successful PC therapy are much fewer. Via appropriate evaluation of patients' conditions and whole-blood samples by simple and sensitive but not yet fully standardized assays, it is theoretically possible that PC quality will be controlled nearly completely. In addition to or instead of standardization of preparation protocols, standardization of preoperative examination of individual PC preparations is an urgent task for improving and guaranteeing the safety and efficacy of PC therapy.