US Greenlights Trials for Pig Kidney Transplants

Approval Granted for Pig Kidney Transplant Research

The U.S. Food and Drug Administration (FDA) has granted approval for clinical trials to transplant genetically modified pig kidneys into human patients with end-stage renal disease. This significant development aims to address the critical shortage of donor organs, with over 100,000 individuals in the U.S. currently awaiting transplants, the majority of whom need kidneys.

Key Details:

• Companies Involved: Two biotechnology firms, United Therapeutics and eGenesis, have received FDA clearance to conduct these trials. United Therapeutics plans to enroll six patients initially, potentially expanding to 50, with the first transplant anticipated in mid-2025. eGenesis received approval in December 2024 for a separate study involving three patients.
• Genetic Modifications: The donor pigs have undergone extensive genetic editing to enhance compatibility with the human immune system. United Therapeutics’ pigs have ten gene modifications, including the addition of six human genes and the removal of four pig genes linked to rejection. eGenesis’ pigs have 69 genomic edits, primarily to disable viruses that could pose risks to human recipients.
• Patient Monitoring: Trial participants will be closely monitored for survival rates, kidney function, and potential zoonotic infections—diseases that can transfer from animals to humans. Lifelong follow-up is planned to assess long-term outcomes.

This initiative represents a pivotal step in xenotransplantation—the transplantation of organs from one species to another. Advances in gene editing and immune system management have brought this field closer to clinical application, offering hope to many patients facing long transplant waiting lists.

The success of these trials could revolutionize organ transplantation, providing a sustainable solution to organ shortages and significantly impacting the future of medical treatments for organ failure.