FDA Approves Large-Scale Human Trials of Genetically Modified Pig Kidney Transplants

 In a groundbreaking decision, the U.S. Food and Drug Administration (FDA) has given the green light for large-scale clinical trials involving genetically engineered pig kidneys transplanted into humans. The move marks a historic step forward in the field of xenotransplantation—the use of animal organs to save human lives.

Pic: Steve Wood/University of Alabama

Why This Matters

More than 100,000 Americans are currently on the waiting list for organ transplants, with kidneys being the most in-demand. Many wait years, and thousands die annually without ever receiving a donor organ. By approving broader testing, the FDA has signaled cautious optimism that xenotransplantation could help solve the organ shortage crisis.

The Science Behind It

Biotech firm eGenesis leads this initiative. Using CRISPR-Cas9 gene-editing technology, its scientists have:

• Edited 68 genes in pigs to reduce the risk of organ rejection.

• Removed three pig genes that human immune systems would typically attack.

• Disabled retroviruses that could theoretically transmit from pigs to humans.

These modifications are designed to make pig kidneys biologically compatible with the human body—an achievement long seen as a “holy grail” in transplantation medicine.

Early Success Stories

Several pioneering surgeries have already taken place:

• Rick Slayman, the first pig kidney recipient, survived two months before passing away from unrelated heart issues.

• Tim Andrews remains alive and healthy, making him the longest-living patient with a pig kidney transplant.

• Bill Stewart, a 54-year-old sports coach, underwent a transplant in June and has since returned to work.

Such cases have offered invaluable data and encouraged regulators to expand clinical testing.

The Next Phase

Under FDA approval, 33 patients will receive pig kidney transplants over the next 2.5 years in eGenesis trials. Another biotech firm, United Therapeutics, is also preparing to launch its own studies.

Dr. Leonardo Riella of Massachusetts General Hospital emphasized that testing the organs in healthier patients—rather than those weakened by years of dialysis—will be crucial in assessing long-term durability.

Patient Support and Public Perception

According to the American Association of Kidney Patients, over 70% of respondents said they would be willing to accept a pig kidney transplant if the FDA approved it. Patient advocacy groups describe this moment as “a profoundly hopeful stage” in tackling the organ shortage crisis.

Looking Ahead

Experts like Dr. Robert Montgomery, a pioneer in xenotransplantation, are astonished at how fast the field is advancing. “No one thought we’d see two FDA-approved trials in less than four years,” he remarked.

If successful, pig organ transplants could redefine modern medicine—turning what was once a futuristic idea into a standard treatment that saves tens of thousands of lives every year.

Source: CNN - TheDawn

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