Title Expert revision of key elements for clinical-grade production and qualification of perinatal derivatives /
Authors Gramignoli, Roberto ; Hofmann, Nicola ; Agudo-Barriuso, Marta ; Antica, Mariastefania ; Flores, Ana I ; Girandon, Lenart ; Kerdjoudj, Halima ; Navakauskienė, Rūta ; Schiavi, Jessica ; Scholz, Hanne ; Shablii, Volodymyr ; Lafarge, Xavier ; Nicolás, Francisco J ; Gindraux, Florelle
DOI 10.1093/stcltm/szad068
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Is Part of Stem cells translational medicine.. Oxford : Oxford University Press. 2024, vol. 13, iss. 1, p. 14-29.. ISSN 2157-6564. eISSN 2157-6580
Keywords [eng] ATMP ; European Regulation ; advanced medical device ; cell therapy ; perinatal derivatives ; placenta
Abstract [eng] Perinatal derivatives have been proposed as adjunct therapeutic strategies or innovative treatments. Undoubtedly, perinatal derivatives can offer the opportunity and source material to isolate multipotent stem cells, but both maternal- and fetal-derived tissues can be processed and transformed into engineered tissues or advanced biomedical devices, whose potential remains to be fully elucidated. Promising preclinical and clinical results collected so far clearly foresee an escalation of such novel treatments. Market forecasts predict exponential growth in such advanced medicinal products during the next decade, with a pragmatic innovation for medicine into a more advanced biomedical version, enlarging the portfolio for treating a wide range of congenital and acute conditions. However, all these promising and fascinating therapeutic possibilities cannot gain a solid and recognized role in established medical practice without rigid and harmonized manufacturing strategies. The implementation of strategies according to guidelines and directives compiled by Regulatory Agencies, in conformity to (European) Pharmacopoeia and for Good Manufacturing Practice -conforming production of such products, represent critical steps required to translate perinatal technologies into effective therapeutic approaches. During the past 5 years, a panel of European experts and developers, gathered under the umbrella of the COST Sprint Action, supported by the European Cooperation in Science and Technology action, had the opportunity to revise and summarize experience and recommendations for a fruitful and proficient generation of perinatal biomedical products. In order to facilitate the creation and potential commercialization of perinatal bioengineered and advanced pharmaceutical products and technologies, such a collection of data and recommendations is described and discussed here.
Published Oxford : Oxford University Press
Type Journal article
Language English
Publication date 2024
CC license CC license description