Pig organ transplantation: clinical trials start in the US
Kyiv • UNN
The FDA has approved two biotechnology companies to conduct clinical trials on transplanting organs from genetically modified pigs. The first trials will begin with six patients with kidney failure in mid-2024.
The U.S. Food and Drug Administration (FDA) has granted two biotech companies approval to conduct clinical trials to transplant organs from genetically modified pigs into patients with kidney failure.
This was reported by The Washington Post, UNN.
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Advances in the field of xenotransplantation - transplanting organs from one species to another - are gaining momentum as scientists develop gene-editing techniques that make organs less prone to rejection.
Until now, such transplants have been approved under the FDA program, which allows the use of investigational drugs outside of clinical trials only when patients are in critical condition and have no other options.
Some medical experts have concerns about the ethical and medical aspects of such transplants, including the risk of contracting animal diseases that spread to humans, and how to help patients effectively weigh the unknown risks.
United Therapeutics Corporation said on Tuesday that its trial will begin with six patients with end-stage renal disease around the middle of this year. Participants in the United Therapeutics study must be between 55 and 70 years old and have been on dialysis for at least six months.
Patients will be monitored for at least 12 weeks after surgery, and an independent review will be conducted before a decision is made to expand the study.
The idea of using pig organs in humans is not new - one of the first recorded cases was in 1838, when a doctor transplanted a pig's cornea into a human in an unsuccessful attempt to correct her eyesight. Pigs are more widespread than some primates, and their organs are more similar to human organs, according to medical experts.
An Alabama woman last month became the longest-lived recipient of a pig organ transplant. Tawana Looney, 53, received a pig kidney in November with 10 gene edits designed to reduce the risk of organ rejection.
The first recipient, Richard Slayman, a 62-year-old employee of the Massachusetts Department of Transportation, lived 52 days after the procedure last year.
Lisa Pisano, a 54-year-old grandmother, received a pig kidney and a heart pump on different days in April last year. She lived 86 days, although the kidney, which was gradually failing, had to be removed after 47 days.
Luna donated her mother's kidney several decades ago and then developed kidney failure due to complications during pregnancy. She was on kidney dialysis for nearly eight years, during which time she developed very high levels of antibodies abnormally set up to attack another human kidney, making it unlikely she would ever receive a donor organ.
Our goal is to increase the availability of organs for transplantation to offer a therapeutic alternative to lifelong dialysis
Recall
53-year-old Tovana Looney has been living with a pig kidney for 61 days after an experimental transplant. The patient, who had previously donated a kidney to her mother, could not receive a human organ due to high levels of antibodies.