
The United States Food and Drug Administration (FDA), in a historic move, allowed the beginning of clinical trials for pig kidney transplants in humans.
According to HealthDay, the FDA has approved the beginning of the first-ever clinical trials testing for pig kidney transplants in kidney failure patients.
The drug administration has given a green light to two biotechnology companies, United Therapeutics Corporation and eGenesis, to start working on their studies. Mike Curtis, president and chief executive 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 who face a low probability of receiving a deceased donor offer within a five-year timeframe.”
Moreover, United Therapeutics Corporation will initially begin the study with six patients who are on dialysis for at least six months without any other serious medical issue, and after the successful first transplant, they will expand the sample size of the study to 50 participants.
Meanwhile, eGenesis will start a trial with three patients and will gradually increase the number of people in the later stages.
The doctors will monitor every single transplant patient for 24 weeks with lifelong follow-up.
If these trials showed promising results, it could revolutionise the whole kidney transplant process and would solve the biggest issue of donor kidney shortage.
As per The Times, over 550,000 people in America have kidney failure, and nearly 100,000 people are on the transplant waiting list. During 2023, less than 25,000 kidney transplants were performed. A large number of patients are required to wait for years to find an odonordonar.