The US Food and Drug Administration has given the green light to two biotechnology companies, United Therapeutics Corporation and eGenesis, to begin clinical trials transplanting organs from genetically modified pigs into people with kidney failure. The trials aim to prove the safety and effectiveness of cross-species transplantation, a long-standing dream in medical science.
United Therapeutics will start its trial with six patients, while eGenesis will begin with three patients. Both companies use pathogen-free facilities and strict biosecurity protocols to reduce the risk of pathogens spreading from pigs to humans. The trials are expected to expand if successful, potentially leading to broader use of cross-species transplantation.
Over 550,000 Americans have kidney failure and require dialysis, but there is an acute shortage of donated organs. This shortage leads to many deaths while waiting for a transplant. Genetically engineered pig organs could provide a solution, but concerns remain about their cost, insurance coverage, and potential risks.
The trials will involve patients with kidney failure who are unlikely to receive a human organ within five years. The companies will monitor the patients for 24 weeks and require regular follow-ups for life to check on their health statuses and detect any pathogens that could cross from pigs to humans.
Critics have raised concerns about the potential risks of such transplants, but medical ethicists acknowledge the need for these experiments. “Fully grasping the lifelong implications of that decision would be even harder” than explaining the risks to someone dealing with dialysis, said Dr. Christopher Bobier.
Source: https://www.nytimes.com/2025/02/03/health/pig-kidney-transplants-clinical-trials.html