World-first pig kidney trials mark turning point for xenotransplantation
Xenotransplantation Breakthrough
The article reports on the US Food and Drug Administration's (FDA) approval of the first clinical trial involving the transplantation of genetically modified pig kidneys into humans. This represents a major turning point in xenotransplantation, a field previously hampered by immunological rejection, viral transmission risks, and ethical considerations.
Significance
Prior to this, xenotransplantation was limited to individual cases under compassionate use protocols. This first-in-human clinical trial has the potential to establish xenotransplantation as a standard medical procedure, offering a life-saving solution for thousands annually facing organ failure.
Challenges Overcome
The success is particularly noteworthy given the historical challenges of xenotransplantation. The article highlights the significant hurdles related to immune system rejection and the risk of cross-species viral infections which have been overcome to enable this clinical trial.
For decades, the promise of xenotransplantation — the transplantation of organs from animals into humans — has remained just beyond reach. The field has long been dogged by immunological rejection, concerns over viral transmission and ethical dilemmas1. But in February 2025, a pivotal moment was reached when the US Food and Drug Administration approved the first clinical trial testing whether kidneys from genetically modified pigs could be safely transplanted into humans. Until then, xenotransplantation had been limited to individual cases approved under compassionate use or expanded access protocols. This pathway allows patients with serious, life-threatening illnesses to access experimental treatments when no other comparable options are available. A first-in-human clinical trial could lay the foundation for xenotransplantation to become a routine medical treatment, potentially saving thousands of lives each year.
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doi: https://doi.org/10.1038/d41591-025-00020-0
The Clinical Pipeline is a column on translational and clinical research, from bench to bedside.
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