Clinical tests for transplanting pig organs into humans commencing
In a groundbreaking development, multiple clinical trials are underway in the United States, exploring the use of genetically modified pig organs for transplantation. These trials, endorsed by the U.S. Food and Drug Administration (FDA), mark a significant step forward in the field of xenotransplantation.
Kidney Transplants
The FDA has given the green light for clinical trials involving genetically engineered pig kidneys, such as the UKidney™ by United Therapeutics. These trials will test 10 gene-modified pig kidneys (with four pig genes knocked out and six human genes added) in patients with end-stage renal disease. Early pig-to-human kidney transplants have already been performed in 2022-2024, demonstrating short-term organ function. The first transplant in the current trial is expected by mid-2025.
Heart Transplants
Historic pig-to-human heart transplants took place in 2023 at the University of Maryland Medical Center. Preclinical studies presented in 2025 showed that genetically modified pig hearts can sustain primate recipients for months, with one lasting nearly 21 months. Immunosuppression regimens, including tegoprubart, are crucial in these successes and are under evaluation for broader transplant types and recipients, including infants.
Liver Treatment
In July 2025, the FDA approved a trial using genetically modified pig livers not as transplant organs but as "dialysis" devices to clean blood in patients with liver failure who are ineligible for liver transplants. This involves circulating patient blood through pig livers extracorporeally and aims to stabilise patients until a transplant or recovery.
These developments reflect a transition from proof-of-concept xenotransplant research to early-stage clinical trials aiming to address organ shortages by using genetically modified pig organs with improved compatibility and immunosuppression strategies. The trials are carefully controlled and monitored to assess safety, organ function, and immune response in humans.
The upcoming clinical trial for pig kidney transplants establishes strict criteria for participant safety and eligibility. Prospective recipients must have a history of end-stage kidney disease, prolonged dialysis treatment, and no severe medical conditions. The trial, set to commence this summer, will initially have a starting cohort of six participants. If successful, it could potentially expand to include up to 50 individuals in the future.
The need for innovative solutions to address organ shortages has never been more pressing. The success of the clinical trial could herald a new era in organ transplantation, offering a lifeline to those in need of life-saving treatments. Notable figures in the field, such as Robert Montgomery of the NYU Langone Transplant Institute, are leading these ground-breaking studies.
Remarkably, Towana Looney, a recipient of a pig kidney transplant, is currently thriving. As these trials progress, we move one step closer to a brighter, healthier tomorrow for those in need of organ transplants. The future of xenotransplantation holds promise for a world where organ shortages are a thing of the past.
- The FDA-approved clinical trials for genetically engineered pig kidneys, such as UKidney™, will test organ function in patients with end-stage renal disease, aiming to alleviate organ shortages.
- Genetically modified pig hearts have shown promise in preclinical studies and heart transplants, with one lasting nearly 21 months in a primate recipient, demonstrating a potential solution for chronic diseases like heart failure.
- The FDA has also approved a trial using genetically modified pig livers as dialysis devices for patients with liver failure who are ineligible for transplants, providing a new approach to health and wellness for those with medical conditions.
- Successful clinical trials for genetically modified pig organs may signify a breakthrough in the field of medical-conditions and medical therapies and treatments, offering hope for people with chronic diseases currently facing organ shortages.
