Expert Revision of Key Elements for Clinical-Grade Production and Qualification of Perinatal Derivatives.

Autor:	Gramignoli R; Department of Laboratory Medicine, Division of Pathology, Karolinska Institutet, Stockholm, Sweden.; Department of Pathology and Cancer Diagnostics, Karolinska University Hospital, Stockholm, Sweden., Hofmann N; German Society for Tissue Transplantation (DGFG) gGmbH, Hannover, Germany., Agudo-Barriuso M; Experimental Ophthalmology Group, University of Murcia and Instituto Murciano de Investigación Biosanitaria (IMIB), Campus Ciencias de la Salud, Murcia, Spain., Antica M; Ruder Boskovic Institute, Division of Molecular Biology, Zagreb, Croatia., Flores AI; Regenerative Medicine Group, Research Institute Hospital 12 de Octubre (imas12), Madrid, Spain., Girandon L; Educell Ltd., R&D Department, Trzin, Slowenia., Kerdjoudj H; University of Reims Champagne Ardenne, EA 4691 BIOS, Reims, France., Navakauskiene R; Department of Molecular Cell Biology, Institute of Biochemistry, Life Sciences Center, Vilnius, Lithuania., Schiavi J; Department of Bioprocesses Biomolecules, University of Lorraine, CNRS, LRGP, Nancy, France., Scholz H; Department of Transplant Medicine, Department of Cellular Therapy, University of Oslo, Oslo, Norway., Shablii V; Laboratory of Biosynthesis of Nucleic Acids, Institute of Molecular Biology and Genetics, Department of Functional Genomics, National Academy of Science, Kyiv, Ukraine.; Placenta Stem Cell Laboratory, Cryobank, Institute of Cell Therapy, Kyiv, Ukraine., Lafarge X; Etablissement Français du Sang Nouvelle-Aquitaine, Laboratoire d'ingénierie tissulaire et cellulaire, Bordeaux, France.; INSERM U1211 « Maladies Rares: Génétique et Métabolisme », Université de Bordeaux, France., Nicolás FJ; Lab. Regeneración, Oncología Molecular y TGFß. IMIB-Pascual Parrilla, El Palmar, Murcia, Spain., Gindraux F; CHU Besançon, Service de Chirurgie Maxillo-Faciale, Stomatologie et Odontologie Hospitalière, F-25000 Besançon, France.; Université de Franche-Comté, LNIT (Laboratoire de Nanomédecine, Imagerie, Thérapeutique EA 4662), F-25000 Besançon, France.
Jazyk:	angličtina
Zdroj:	Stem cells translational medicine [Stem Cells Transl Med] 2024 Jan 12; Vol. 13 (1), pp. 14-29.
DOI:	10.1093/stcltm/szad068
Abstrakt:	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. (© The Author(s) 2023. Published by Oxford University Press.)
Databáze:	MEDLINE
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