BACKGROUND: The lack of human donors for allotransplantation forces the development of other strategies to circumvent the existing organ shortage documented on the waiting lists. Here, xenotransplantation offers a suitable option since the genetic modification of animals has become an established method that allows the generation of animals as donors of cells, tissues, and organs with reduced antigenicity. METHODS: Focus is given on the generation of decellularized matrix scaffolds, for example, for valve transplantation and/or repair, that have the potential being fully assimilated by the recipient as they are no longer a mechanical implant with risk of calcification and related failure. RESULTS: This new class of products is transplants that will be regulated either as medical devices or as cell-based medicinal products, that is, advanced therapy medicinal products, according to the regulations in the European Union. CONCLUSIONS: In this review, we compile relevant regulatory aspects and point out the possibilities of how these products for human use may be regulated in the future.
BACKGROUND: The lack of human donors for allotransplantation forces the development of other strategies to circumvent the existing organ shortage documented on the waiting lists. Here, xenotransplantation offers a suitable option since the genetic modification of animals has become an established method that allows the generation of animals as donors of cells, tissues, and organs with reduced antigenicity. METHODS: Focus is given on the generation of decellularized matrix scaffolds, for example, for valve transplantation and/or repair, that have the potential being fully assimilated by the recipient as they are no longer a mechanical implant with risk of calcification and related failure. RESULTS: This new class of products is transplants that will be regulated either as medical devices or as cell-based medicinal products, that is, advanced therapy medicinal products, according to the regulations in the European Union. CONCLUSIONS: In this review, we compile relevant regulatory aspects and point out the possibilities of how these products for human use may be regulated in the future.
Authors: Kritika S Katiyar; Justin C Burrell; Franco A Laimo; Kevin D Browne; John R Bianchi; Anneke Walters; David L Ayares; Douglas H Smith; Zarina S Ali; Harry C Ledebur; D Kacy Cullen Journal: Tissue Eng Part A Date: 2021-04-09 Impact factor: 4.080
Authors: Ana Lídia Jacintho Delgado; Ana Claudia Oliveira Carreira; Hianka Jasmyne Costa de Carvalho; Renata Kelly da Palma; Taís Harumi de Castro Sasahara; Carla Maria Figueiredo de Carvalho; Marisol León; Rodrigo da Silva Nunes Barreto; Maria Angélica Miglino Journal: J Clin Transl Res Date: 2021-08-08