In a historic move, the U.S. Food and Drug Administration (FDA) has allowed the initiation of clinical trials for pig kidney transplants in humans.
According to HealthDay, the FDA has granted approval for the first-ever clinical trials testing pig kidney transplants in patients with kidney failure.
The administration has given the green light to two biotechnology companies, United Therapeutics Corporation and eGenesis, to begin their studies. Mike Curtis, president and CEO of eGenesis, told The New York Times, “We are entering a transformative era in organ transplantation.”
eGenesis said, “The study will evaluate patients with kidney failure who are listed for a transplant but face a low probability of receiving a deceased donor offer within a five-year timeframe.”
Moreover, United Therapeutics Corporation will begin the study with six patients who have been on dialysis for at least six months without other serious medical issues. After the first successful transplant, they will expand the sample size to 50 participants.
Meanwhile, eGenesis will start with three patients and gradually increase the number of participants in later stages.
Doctors will monitor each transplant patient for 24 weeks, with lifelong follow-up.
If these trials show promising results, it could revolutionize the entire kidney transplant process and address the critical shortage of kidney donors.
According to The Times, over 550,000 people in the U.S. have kidney failure, and nearly 100,000 are on the transplant waiting list. In 2023, less than 25,000 kidney transplants were performed. As a result, many patients are required to wait for years to find a donor.
