Expert Consideration on Regulatory Aspects for Perinatal Derivatives in Clinical Settings

• Published in: Stem cells translational medicine 2023-05, Vol.12 (5), p.258-265
• Main Authors: Hofmann, Nicola, Lafarge, Xavier, Antica, Mariastefania, Ferry, Nicolas, Girandon, Lenart, Gramignoli, Roberto, Jurga, Marcin, Kerdjoudj, Halima, Navakauskiene, Ruta, Schiavi, Jessica, Shablii, Volodymyr, Nicolás, Francisco J, Gindraux, Florelle
• Format: Article
• Language: English
• Subjects: Biotechnology; Cell- and Tissue-Based Therapy; Concise Reviews; European Union; Human health and pathology; Life Sciences; Medicin och hälsovetenskap
• ISSN: 2157-6564; 2157-6580; 2157-6580
• DOI: 10.1093/stcltm/szad017

Abstract Perinatal derivatives (PnD) are drawing growing interest among the scientific community as an unrestricted source of multipotent stem cells, secretome, and biological matrices. They are useful for the treatment of diseases that currently have limited or no effective therapeutic options, but they require the development of regenerative approaches. With this development, the question of regulation of donation, processing, and distribution has therefore become more important. Within the European Cooperation in Science and Technology (COST) community, we compiled a group of international experts on PnD technologies, who revised and compared existing EU national regulations. Notably, despite clear European directives, each EU Country has developed their own implementation and standard levels for cell- and tissue-based therapies. To enable extended applications of PnD treatments within the EU community and worldwide, harmonization is highly recommended. This paper aims to provide an overview of the various options available to introduce PnD into clinical practice. For this purpose, the different aspects resulting from (1) the type of PnD, (2) the amount of available data, (3) the degree of manipulation, and (4) the intended application and the process toward a possible commercialization will be presented. In the future, it will be important to find a balance between regulatory requirements and the best medical quality of the PnD product. Graphical Abstract This summary shows the origin of different types of PnD related to the degree of manipulation. The various PnD are typically processed to different degrees, so the resulting products are subject to distinct regulatory pathways. The higher the degree of manipulation, the more extensive are usually the requirements for approval.