The FDA approves the tests of swine organs transplants

The American Food and Medicine Agency has donated the green airy to two biotechnology companies to clinical trials that transplant organs from genetically modified pigs to people with kidney failure. If it succeeds, these studies can lead to a broader operate of transplant between species, the dream of medical scientists for centuries.

One of the companies, United Therapeutics Corporation, will start a study with six patients, but this number may eventually escalate to 50. The second, Egeneza, said that she would start from three patients and from now on the examination would escalate.

“We are introducing a transformation era in organ transplant,” said Mike Curtis, president and general director of Egeneza.

Over the past three years, five patients receive organs from pigs designed by these companies – two that have received hearts and three that have received the kidneys. But these operations were not part of a formal clinical trial. Most patients were critically ill and their transplants were allowed because they lacked other treatment options.

Looney, a 53-year-old woman from Alabama, is the longest surviving so far survivor, who in November received a pig’s kidney at Nyu Langone Health in Modern York. The other four organs recipients who were more infirmed when they underwent transplants died shortly after the surgery.

Over 550,000 Americans have kidney failure and requires dialysis, and about 100,000 of them are on the renal waiting list. But there is a pointed shortage of donated organs, with less than 25,000 transplants in 2023. Many people die while waiting.

Even if genetically prepared pig organs turn out to be secure and effective, it is not clear how much they cost and whether they would be covered by insurance.

United Therapeutics, which is to start in the middle of the year, will start with six patients who were dialysis for at least six months, but do not have other stern medical problems. There will be a three -month waiting period between each transplant so that doctors can learn from the results.

If the first six transplants are successful, the study will expand to 50 participants in the so -called phase study – a type of research that combines established phase 1, phase 2 and phases 3 and can lead directly to approval.

Patients will be monitored for 24 weeks and must agree to regular observations for the rest of their lives, enabling researchers to check not only their health status, but also pathogens that could go from pigs to people.

Critics aroused concerns about the potential of known or unknown pathogens in pigs to spill into the human population during such transplants, although the risk is believed to be miniature. Both companies raise their pigs in pathogens free of pathogens that come to strict biological safety protocols and regularly check animals for pathogens.

Medical ethics also asked questions about how patients can fully agree to such experiments when there are so many unknown risks.

In the worst case, the recipient of the animal’s body, “an undetected pathogen from a pig source could be infected,” said Christopher Bobier, an associate professor specializing in bioethics and health policy at Central Michigan University College of Medicine.

He also said that it is hard to explain this risk to someone who deals with the exhausting nature of kidney dialysis, which involves connecting to a dialysis machine for three to four hours a day, three times a week. “The saying that it would not be extremely hard,” said Dr. Bobier. “Full browsing throughout your life implications of this decision would be even more hard.”

The kidneys produced by United Therapeutics come from pigs that have undergone 10 editions of the genes to improve the compatibility of their organs with human hosts: six human genes have been added and four pig genes have been inactivated – one that limits the growth of organs and three, which can cause growth of human organs .

Egenesis traps have undergone 69 editions of the genes, including changes in 59 genes for inactivated viruses that are integrated with the pig genome.

Dr. Curtis said that egenesis will start with three patients with kidney failure, who are unlikely to accept the human organ. There will be a six -month waiting period between the first and second patient, and then three months later before the third, said the company.