Xenotransplantation of decellularized pig heart valves-Regulatory aspects in Europe.

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.