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.
Keywords: Xenotransplantation; advanced therapy medicinal product; cell therapy medicinal product; decellularization; gene therapy medicinal product; medical device; medicinal product; non-vital tissue preparation; tissue-engineered product; xenograft; xenotransplant.
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