FDA Approves Clinical Trials for Transplanting Genetically Modified Pig Organs into Kidney Failure Patients

The Food and Drug Administration has approved two biotechnology companies to conduct clinical trials involving the transplantation of genetically modified pig organs into patients with kidney failure. This potential breakthrough offers hope to many Americans who are waiting for organ transplants.

United Therapeutics Corp. announced that their trial will involve six patients with end-stage renal disease starting in mid-2023. The trial may expand to include up to 50 patients who are either unable to accept a donor kidney for medical reasons or are unlikely to receive a kidney within five years.

Another company, eGenesis, revealed it received FDA approval for a study to transplant kidneys into three patients, with the possibility of further expansion.

"We are entering a transformative era in organ transplantation," said eGenesis chief executive Mike Curtis.

In the United States, over 106,000 individuals are on the waiting list for organ transplants, with a significant number seeking kidney transplants. In 2023, only roughly 27,000 kidney transplants were performed, and over 557,000 patients currently rely on dialysis.

Advancements in xenotransplantation, specifically the transplantation of organs from one species to another, have been accelerating. Scientists have developed gene-editing techniques aimed at decreasing organ rejection chances.

Until now, such transplants were performed under the FDA's compassionate-use program, which is restricted to critically ill patients who have limited options.

Some experts have raised concerns regarding the ethics and health implications of these transplants, including the risk of infections from animal-specific diseases and how to inform patients adequately about potential risks.

The United Therapeutics trial participants must be between 55 and 70 years old and have been on dialysis for a minimum of six months. Medical monitoring will continue for at least 12 weeks post-surgery, with an independent review prior to potential study expansion.

The concept of using pig organs for human transplants is not new; the first recorded instance occurred in 1838 when a pig cornea was transplanted into a human. Pigs present advantages due to their availability and the similarity of their organs to humans.

Recently, an Alabama woman became the longest-living recipient of a pig organ transplant. Towana Looney, 53, received a genetically modified pig kidney with alterations aimed at minimizing rejection risk.

Healthcare professionals emphasize the goal of increasing transplantable organ availability to provide alternatives to patients who rely on dialysis.