Xenotransplantation of decellularized pig heart valves-Regulatory aspects in Europe.
Xenotransplantation
; 27(3): e12609, 2020 05.
Article
em En
| MEDLINE
| ID: mdl-32449225
ABSTRACT
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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Transplante Heterólogo
/
Regulamentação Governamental
/
Valvas Cardíacas
Limite:
Animals
/
Humans
País/Região como assunto:
Europa
Idioma:
En
Ano de publicação:
2020
Tipo de documento:
Article