First Clinical Trial of Pig Kidney Transplants Begins in the US

The first clinical trial testing the transplantation of pig kidneys into humans has commenced in the United States. United Therapeutics, a company specializing in gene-edited pig organs, announced the successful completion of the initial transplant at NYU Langone Health in New York City. This trial marks a significant step in the ongoing exploration of xenotransplantation, the process of transplanting organs from one species to another.

eGenesis, another US-based company, plans to launch its own clinical trial involving pig kidneys in the near future. The current trial at NYU is the first of its kind globally, focusing on the potential of animal-to-human organ transplants. To maintain confidentiality, details regarding the timing of the surgery and specific patient information have not been disclosed.

Trial Details and Future Plans

The transplant team, led by Dr. Robert Montgomery, has indicated that they have a list of additional patients eager to participate in the small-scale trial, which will initially involve six individuals. If the initial results are promising, the trial could expand to include up to 50 participants as more transplant centers become involved.

The US Food and Drug Administration (FDA) has approved these rigorous studies following a series of “compassionate use” cases, which yielded mixed outcomes. Previous attempts at gene-edited pig kidney transplants lasted only a short time. However, the approach has shifted to focus on patients who require a kidney but are not critically ill, allowing for improved outcomes.

In one case at NYU, a woman’s transplanted pig kidney functioned for 130 days before she required dialysis again. Another patient at Massachusetts General Hospital achieved a record of 271 days with a pig kidney before the organ began to decline and was subsequently removed. Other patients known to be living with pig kidneys include another individual at Massachusetts General and a woman in China.

The Need for Organ Transplants

The need for organ transplants is urgent. In the United States alone, over 100,000 people are on the transplant list, with the majority awaiting kidney transplants. Thousands die each year while waiting for suitable organs. In Europe, more than 10,000 people are on the kidney waiting list, according to the Eurotransplant International Foundation, which coordinates organ donations across several countries.

As a potential solution, scientists are genetically modifying pigs to create organs that are more compatible with the human immune system. United Therapeutics is conducting its trial using pig kidneys that have undergone 10 gene edits. These modifications aim to eliminate genes responsible for early rejection and excessive organ growth while integrating some human genes to enhance compatibility.

Dr. Montgomery expressed optimism about the progress being made, stating, “This thing is moving in the right direction” as the medical community learns from each patient’s experience. The ability for patients to return to dialysis provides a significant safety net, making the exploration of xenotransplantation a promising avenue in addressing the critical shortage of organ donors.