Division of Oral Bioengineering, Institute of Medicine and Dentistry, Niigata University, Niigata 951-8514, Japan.
Division of Periodontology, Institute of Medicine and Dentistry, Niigata University, Niigata 951-8514, Japan.
Biomed Res Int. 2018 May 21;2018:6389157. doi: 10.1155/2018/6389157. eCollection 2018.
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.
血小板浓缩物（PCs），以富含血小板的血浆（PRP）为代表，已广泛应用于再生和美容疗法领域。然而，PCs 的作用机制过于复杂，很难全面呈现；此外，在许多情况下，临床结果难以重现。因此，由于其日益普及，一些医学先进国家似乎有意对 PC 治疗进行弱或严格监管。日本于 2014 年在《再生医学安全法》和《药品、医疗器械和其他治疗产品法》中制定了 PC 治疗法规，这代表了世界上对 PC 生产和治疗使用最严格的监管框架。根据这些法律法规，用于局部使用的 PCs 应按照其注册（实际情况下“许可”）标准操作程序，作为细胞药物产品制备，基本上应与干细胞一样。尽管如此，其质量标准并未标准化。在这篇综述中，我们通过关注日本再生医学的基本概念和监管框架来讨论 PC 制剂的质量。在新框架内，PC 治疗受到特定通知和注册系统的监管，与干细胞治疗相同。然而，与后者相比，阻碍成功 PC 治疗的风险因素要少得多。通过对患者情况和全血样本进行适当评估，使用简单、敏感但尚未完全标准化的检测方法，理论上可以近乎完全控制 PC 质量。除了标准化制备方案外，标准化个体 PC 制剂的术前检查也是提高和保证 PC 治疗安全性和疗效的紧迫任务。
