Pork organ transplants will finally begin clinical trials this year

Animal organ transplants to humans reach the milestone of the long -awaited tests

By Tanya Lewis Edited by Dean Visser

The US Food and Medicines Administration recently approved the first Clinical trial From the transplant of a non -human animal organ, a genetically modified pork kidney, in living human receptors. The study will start mid -year and initially involve six participants, but it could eventually include up to 50.

The study will allow researchers to evaluate the security and effective years.

“It is a very important milestone,” says Robert Montgomery, president of the Department of Surgery and director of Nyu Langone Trasplant Institute, who according to him is one of the two sites for the study. A clinical trial “is the gold standard to evaluate the safety and effectiveness of a new medicine or treatment.”

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More than 103,000 people In the United States, they are currently waiting for an organ transplant, and the scarcity of donor organs means that many will die before one is available. The idea of ​​xenotransplants, operations to transplant organs from other animals to humans, has existed for at least a century. Early attempts Used kidneys, hígados and hearts of babouins, chimpanzees and other creatures. Most of these first experiments failed, in large part because the host immune system rejected the organ of the other species. But in recent years, the great advances in genetic manipulation have revived xenotransplantation efforts.

Clinical trials are important because they have clear end points for safety and efficacy data, as well as guidelines to establish who can participate and to ensure that no adverse event is informed. A handful of surgeries outside this framework has been allowed, but these could only provide limited data compared to a formal trial.

In 2022, a patient named David Bennett became the first person living in receiving a genetically modified pork transplant. A team of the Faculty of Medicine of the University of Maryland performed the surgery using a kidney with 10 editions to its genetic code of a pig designed by revivicor (a subsidiary of United Therapeutics, the company that provides the organs for the new trial). Unfortunately, Bennett developed complications and He died two months later.

The following year, the teams of Nyu Langone Health and the University of Alabama in Birmingham transplanted to the pork kidneys of a single gene in human receptors that had suffered brain death but had some body systems artificially maintained for a short time. The families of the recipients had consented to let scientists do it to study the function of the organs. Then, last March, Richard Slayman became the first person living in receiving a modified pork kidney, one with 69 genetic editions made by a company called Egenesis. Slayman, who was already seriously ill before surgery, died almost two months later. Since then, two genetically modified kidney xenotransplants have been made: last year Nyu Langone Health transplanted a woman’s kidney to a woman named Towana Looney, which is It is still fine Almost three months later. And last week, Tim Andrews, patient at the Massachusetts General Hospital, He received a pork kidney made by egénesis.

Some of these surgeries were approved under the “Expanded Access” program of the FDA, which allows very sick people to receive experimental treatments on a compassionate use. Others were part of a small pilot study of pork bodies of Egénesis that the FDA was green. But researchers had expected a complete clinical trial, which would allow a broader and healthier range of individuals to be enrolled to better evaluate Xenotransplant’s viability in a broader population.

The new essay will evaluate the rate of adverse events or death for any cause and the amount of protein in the urine (a sign of renal malfunction), as well as zoonotic infections (those transported by animals) and other infections, according to Dewey Steadman. , Head of relations with investors at United Therapeutics. It is a combined clinical trial of phase 1-2-3, which means that it will evaluate both safety and efficacy continuously. After the first transplant, there will be a waiting period of 12 weeks. Once the first six patients have been transplanted for 12 weeks, an independent committee will evaluate the safety and effectiveness of the procedure before expanding to a larger cohort of up to 50 people.

The kidney for each transplant, called “Ukidney” by its creators, will come from pigs with 10 genetic editions: six human genes add that they make the organ more compatible with the human immune system and four inactivated genes that can cause rejection or rejection or rejection or rejection or rejection or I rejection make the organ grow too large.

To qualify for the trial, participants must adjust one of the two criteria: or they should not qualify to be listed for a human kidney transplant, or they may be on the transplant list, but it is unlikely to receive an organ, or it is They probably die before they do so, in five years. All participants will have a renal disease in the terminal stage and have been on dialysis for at least six months. They must also be free from other serious medical problems. On the contrary, most people who have received a xenotransplant on a basis of compassionate use have been seriously ill, which hinders the evaluation of the success of the transplant itself.

“This is the culmination of years of work with the FDA, which have been incredibly collaborative in this process,” says Steadman. “Both we and the FDA are really committed to bringing this [technology] to the market to help patients who do not have other options at this time in addition to dialysis. “