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The research offers hope to tens of thousands of patients with kidney failure who are on a long waiting list for an organ transplant.
American regulators have given the green light to two biotechnology companies for clinical trials that will transplant organs from genetically modified pigs into people with kidney failure. If successful, these studies could lead to the broader use of cross-species transplantation, a dream of medical scientists for centuries.
One of the companies, United Therapeutics Corporation, will begin its trial with six patients, but that number could eventually rise to 50. The other, eGenesis, said it would begin with three patients and grow the study from there.
“We are entering a transformative era in organ transplantation,” said Mike Curtis, the president and chief executive of eGenesis.
Over the past three years, five patients have been known to receive organs from pigs engineered by these companies — two who received hearts and three who received kidneys. But these surgeries were not part of a formal clinical trial. Most of the patients were critically ill and their transplants were allowed because they had run out of other treatment options.
The longest survivor to date is Towana Looney, a 53-year-old woman from Alabama who received a pig’s kidney at NYU Langone Health in New York City in November. The four other organ recipients, who were far sicker when they underwent the transplants, died shortly after the procedures.
More than 550,000 Americans have kidney failure and require dialysis, and about 100,000 of them are on a waiting list to receive a kidney. But there is an acute shortage of donated organs, with fewer than 25,000 transplants done in 2023. Many people die while waiting.