FDA approves research on pork organs in kidney patients

The United States Food and Pharmaceutical Bureau has given two biotechnology companies green light for clinical trials that are diagnosed from genetically modified pigs to renal failure. If you succeed, these studies can lead to a wider range of use of the pace of medical scientists for several centuries.

One of the companies, United Therapeutics Corporation, starts testing with six patients, but the number will eventually increase to 50. Another EGENESIS started with three patients and then grew research.

“We are in a transplanted era in organ transplant,” said Mike Curtis, president and highest executive of EGENESIS.

It is known that five patients will receive organs from pigs designed by these companies in the past three years. However, these surgery was not part of the official clinical trial. Most patients were seriously ill and had no other treatment options, so transplantation was allowed.

The longest survivor in the past is TOWANA LOONEY, a 53 -year -old woman from Alabama, who received a pig kidney in NYU Languone Health in New York City. The four other organ recipients, who were much more ill during the transplant, died shortly after the treatment.

More than 550,000 Americans have renal failure, need dialysis, of which about 100,000 are on the standby list to receive the kidneys. However, in 2023, a donation organs with less than 25,000 transplants are underway. Many people have died while waiting.

Even if the genetic recombinant pig organs are proved to be safe and effective, it is unknown what they are spending and covered with insurance.

UNITED THERAPEUTICS study, which is expected to begin in the mid -year, begins with six patients who have been dialysis for at least six months but have no other serious medical problems. There is a three -month waiting period between each transplant, so that doctors can learn from the results.

If the first six transplants are successful, the exams will be expanded, and the phase restorial will include up to 50 participants. This is a type of study that combines the test of conventional phase 1, phase 2, and phase 3, which may directly connect to approval.

Patients must be monitored for 24 weeks and need to agree to regular follow -up of the remaining life. As a result, researchers can check not only their health, but also pathogens that may travel from pigs to humans.

Critics are considered to be small, but have raised concerns about the possibility that pigs known for pigs or unknown pathogens spread to their population during such transplantation. The two companies are complying with strict bi -security protocols and raising pigs in facilities without pathogens that regularly screen the pathogen animals.

In addition, medical ethics questioned how many unknown risks could be fully agreed in such experiments.

In the worst scenario, Christopher Bobie, an associate professor who specializes in bioprosis and health policy at the Central Michigan University School of Medicine, states:

He also stated that it was difficult to explain these risks to those who deal with the harsh nature of kidney dialysis. “It would be very difficult to say no,” said Dr. Bobie. “It will be even more difficult to fully understand the meaning of the decision.”

The kidneys generated by United Therapytics were born from 10 gene editing pigs to improve the compatibility between organs and human hosts. Six human gene was added, and four pig gene was inactivated. Human rejection.

EGENESIS PIGS received 69 gene editing, including 59 gene changes to inactivate the virus integrated into a pig genome.

Dr. Curtis said that the equivalent exams will begin with three patients with renal failure, which is unlikely to receive human organs within five years. The company said there was a six -month waiting period between the first patient and the second patient, and three months later, three months later.