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Expert Consideration on Regulatory Aspects for Perinatal Derivatives in Clinical Settings

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 req...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10184691/
https://www.ncbi.nlm.nih.gov/pubmed/37027834
http://dx.doi.org/10.1093/stcltm/szad017
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author 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
author_facet 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
author_sort Hofmann, Nicola
collection PubMed
description 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.
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spelling pubmed-101846912023-05-16 Expert Consideration on Regulatory Aspects for Perinatal Derivatives in Clinical Settings 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 Stem Cells Transl Med Concise Reviews 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. Oxford University Press 2023-04-07 /pmc/articles/PMC10184691/ /pubmed/37027834 http://dx.doi.org/10.1093/stcltm/szad017 Text en © The Author(s) 2023. Published by Oxford University Press. https://creativecommons.org/licenses/by-nc/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com.
spellingShingle Concise Reviews
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
Expert Consideration on Regulatory Aspects for Perinatal Derivatives in Clinical Settings
title Expert Consideration on Regulatory Aspects for Perinatal Derivatives in Clinical Settings
title_full Expert Consideration on Regulatory Aspects for Perinatal Derivatives in Clinical Settings
title_fullStr Expert Consideration on Regulatory Aspects for Perinatal Derivatives in Clinical Settings
title_full_unstemmed Expert Consideration on Regulatory Aspects for Perinatal Derivatives in Clinical Settings
title_short Expert Consideration on Regulatory Aspects for Perinatal Derivatives in Clinical Settings
title_sort expert consideration on regulatory aspects for perinatal derivatives in clinical settings
topic Concise Reviews
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10184691/
https://www.ncbi.nlm.nih.gov/pubmed/37027834
http://dx.doi.org/10.1093/stcltm/szad017
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