Xenotransplantation

Xenotransplantation is the transfer of living cells, tissues or organs between different species, e.g. from pigs to humans.

This method is considered a potential solution to the shortage of human donor organs. In recent years, clinical research has significantly contributed to making cardiac xenotransplantation of genetically modified pig hearts in humans possible. A crucial milestone was the transplantation of such a heart in January 2022.

A central problem is the rejection reaction, which is more severe than in transplants between humans. To address this, genetically modified animals are used, whose organs are more compatible.

In Europe, clinical trials on xenotransplantation are monitored through a combination of national and European regulations. The European Medicines Agency (EMA) plays a key role in evaluating the safety and efficacy of xenogeneic cell-based medicinal products, which are part of the regulatory framework for Advanced Therapy Medicinal Products (ATMPs). National health authorities, such as the Paul Ehrlich Institute in Germany, are also involved, particularly in the approval and monitoring of studies

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