The Food and Drug Administration agrees to the studies of swine members’ transplantation for kidney patients
American organizers gave the green light to the biotechnology company for clinical trials that will grow organs from genetically modified pigs to people with kidney failure. If it succeeds, these studies can lead to the broader use of cultivation of crossed species, which is the dream of medical scientists for centuries.
One of the companies, the United Therapics Corporation, will start trying with six patients, but this number may eventually rise to 50.
“We are entering a transformative era in the organ transplant,” said Mike Cortis, president and CEO of Egenesis.
Over the past three years, it has been known that five patients receiving members of pigs designed by these companies – two hearts and three who received the kidneys. But these surgeries were not part of an official clinical trial. Most patients had serious diseases and their implants were allowed because they ran out other treatment options.
The longer survivors so far is Towana Looney, a 53 -year -old woman from Alabama who got a pork college at Nyu Langone Health in New York City in November. The other four received, who were more ill, died when they underwent transplants, shortly after the procedures.
More than 550,000 Americans suffer from kidney failure and require dialysis, and about 100,000 of them are included in the waiting list to receive the college. But there is a sharp deficiency in the donated organs, with less than 25,000 transplants in 2023. Many people die while waiting.
Even if the genetically designed pigs prove that they are safe and effective, it is unclear what will cost him and whether it will be covered with insurance.
The UNIDEUTICS study, which is expected to start in the middle of the six -patient work period who were in dialysis for at least six months but they have no other serious 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 succeed, the experiment will expand to include up to 50 participants in the so -called feasibility experience – a type of study that combines the experiences of the first stage, the second stage and the third stage and can lead directly to approval.
Patients will be monitored for 24 weeks and must agree to a regular follow -up to the rest of their lives, allowing researchers to verify not only their health conditions but also for pathogens that can cross pigs to humans.
Critics raised concerns about the possibility of known or unknown pathogens in pigs to spill to human population during these transplants, although the danger is small. Both companies raise their pigs in facilities free of pathogenic factors that adhere to strict biomedic protocols and animal examination regularly for pathogens.
Medical ethics also raised questions about how patients fully agree to such experiments when there are a lot of unknown risks.
“In the worst government scenario, he can develop animal devices” with an uncomfortable actress from the source of the pig.
He also said that it was difficult to explain these risks to a person who deals with the arduous nature of dialysis, which involves connecting a dialysis machine for three to four hours a day, three times a week. “The saying will not be very difficult,” said Dr. Boubir. “The assimilation of antiquities for this decision will be more difficult.”
The kidneys produced by the UNIDEUTICS pigs come from pigs that have undergone ten genetic adjustments to improve the compatibility of their organs with the human hosts: six human genes and four genes of pigs are added – one restricts organ growth and three can cause human rejection.
The preparation pigs have undergone 69 genetic adjustments, including Changes in 59 genes to disable viruses that are combined into the pig’s genome.
Dr. Cortis said that the trial of Egenesis will start with three patients with kidney failure and who are unlikely to obtain a human member within five years. The company said that