The FDA has approved two biotechnology companies to begin clinical trials of xenotransplantation, a procedure whereby genetically modified pig organs are transplanted into humans. The breakthrough offers new hope for thousands of Americans suffering kidney failure, many of whom are on the transplant waiting list, The Washington Post reported Feb. 4.
Here are five notes:
- United Therapeutics Corp. announced Feb. 4. that it will start a trial in mid-2025 with six patients who have end-stage renal disease. These patients, who have been on dialysis for at least six months, will undergo transplants using pig kidneys with genetic edits designed to minimize rejection.
The study could eventually expand to 50 participants, particularly those who are unable to receive a human kidney or are unlikely to receive one within five years.
- Meanwhile, eGenesis, another biotech company, received FDA approval in December to proceed with a kidney transplant study involving three patients. Dr. Mike Curtis, MD, CEO of eGenesis hailed the approval calling it a "transformative era in organ transplantation."
- Currently, over 106,000 people are on the national waiting list for organ transplants, with a large majority needing kidneys. In 2013, only about 27,000 kidney transplants were performed while over 557,000 patients remain on dialysis.
- Advances in xenotransplantation have accelerated, fueled by gene-editing technology that makes pig organs more compatible with the human immune system.
- However, ethical and health concerns persist among experts who worry about the risks of animal-to-human disease transmission and how patients will weigh the potential dangers of the novel approach.
- However, success cases have stirred optimism in the field. For example, Towana Looney, a 53-year-old woman from Alabama recently became the longest-living recipient of a gene-edited pig kidney. She had been on dialysis for nearly eight years and was deemed highly unlikely to receive a human kidney due to high antibody levels that would make the transplant risky.
The transplant, carried out in November 2024 at NYU Langone Health in New York City is now considered a key milestone in the field.