HAMBITIOUS

FDA Greenlights Human Trials for Pig Kidney Transplants

New technology using genetically modified pigs’ organs could help cut the U.S. transplant waitlist.

The FDA has granted approval for the first-ever clinical trials testing pig kidney transplants in human patients, a major step in the effort to address a nationwide organ shortage, The Washington Post reports. Two biotechnology companies, United Therapeutics and eGenesis, received the green light to begin trials using genetically modified pig kidneys, with the first procedures expected this year. United Therapeutics plans to start with six patients suffering from end-stage renal disease, expanding to 50 if successful. Meanwhile, eGenesis received approval in December for a smaller trial of three patients. “We are entering a transformative era in organ transplantation,” eGenesis CEO Mike Curtis told the Post. Scientists hope these transplants, made possible by genetic modifications that reduce organ rejection, will provide an alternative for the more than 100,000 people currently on the U.S. transplant waitlist. While previous pig organ transplants have been done under emergency compassionate-use authorization, the new clinical trials are the first regulated study to assess long-term viability. Medical experts continue to debate ethical and safety concerns, including the risk of animal-borne infections, but proponents believe the pig kidneys could revolutionize the future of organ transplantation.

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