Abstract

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.

Highlights

  • Regenerative therapy using platelet concentrates (PCs), such as platelet-rich plasma (PRP), is an adjuvant biological therapy [1, 2]

  • We introduce the basic concept of the regulatory frameworks for cell-based medicinal products (CBMPs) in Japan, analyze the current situation and understanding of PC therapy, and propose the Must-Do list for improving the quality of PC therapy

  • Contradictory results regarding efficacy have always been attributed to the differences in individual samples and preparation protocols without careful consideration or discussion, while safety has been endorsed seemingly without careful or long-term standardized evaluation

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Summary

Introduction

Regenerative therapy using platelet concentrates (PCs), such as platelet-rich plasma (PRP), is an adjuvant biological therapy [1, 2]. Despite more than 2 decades of use of PCs in various areas of regenerative medicine, the essence of PC therapy seems not to be regarded correctly by many clinicians: basically, the mechanisms of its action are not yet fully clarified and wide variations of its clinical outcomes remain to be clearly explained. For these reasons, some regulatory authorities in individual countries are seemingly intending to regulate medical use of PCs by establishing a new regulatory framework. We introduce the basic concept of the regulatory frameworks for cell-based medicinal products (CBMPs) in Japan, analyze the current situation and understanding of PC therapy, and propose the Must-Do list for improving the quality of PC therapy

The World Is Changing
Quality of PCs
General Risk Factors in Cell-Based Therapy and Possible Risks of PC Therapy
Possible Case-Specific Risks Related to Contraindications
Indications and Contraindications
Conclusion
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