The FDA has granted United Therapeutics and eGenesis approval to begin clinical trials on gene-edited pig kidneys for human transplants, marking a major step in addressing the U.S. organ shortage.
Over 100,000 people await transplants, with kidney replacements making up the majority of cases.
United Therapeutics plans to transplant pig kidneys into six end-stage renal disease patients by mid-2025, with potential expansion to 50 participants. Meanwhile, eGenesis will study three patients unlikely to receive a human kidney within five years, assessing the viability of xenotransplantation.
While gene-edited pig organs offer hope, risks remain, including immune rejection and zoonotic infections.
The only documented pig kidney recipient, Towana Looney, has survived for 71 days post-transplant, surpassing previous attempts in cross-species transplantation.
