FDA Authorizes Clinical Trials for Pig Organ Transplant

livewell
February 5, 2025
Noah Bennett

FDA has permitted conducting clinical trials for patients who have kidney failure by transplanting genetically modified pig kidneys into them. Starting later this year, the trial will commence with the transplanting of pig kidneys into patients suffering from kidney disease. This process of pig organ transplant represents vigor in efforts to resolve the significant gap in human organ donations. Also, it offers renewed hope to thousands waiting for life-saving kidney transplants.

Addressing the Organ Shortage Crisis

Kidney failure affects millions across the globe and many suffer through long hours of dialysis awaiting appropriate donor organs. Lack of kidneys is causing significant illness and death among patients listed for transplants. FDA-approved trials could solve this issue through xenotransplantation – organ transplant from one species to another.

FDA’s approval allows the experimental procedure to cater to those needing an organ as a donor. Jay Fishman who specializes in Infectious Diseases Post-Transplantation at Massachusetts General Hospital, expresses optimism about the official commencement of clinical trials.

From the US and China

Previous clinical trial cases have documented where patients went through heart transplants obtained from genome-edited pigs. However, the surgeries were only performed on a compassionate basis. Recipients rarely survived the initial few months due to being gravely ill prior with other reasons being postoperative complications they were too weak to tolerate.

Fishman states how kidney patients have xenotransplants that greatly assist the efforts of healthcare professionals. Nevertheless, formal clinical trials are a set process, meaning they can provide some of the key data needed to advance the work such as safety.

Fundaments of this Trial

As the Maryland-based biotechnology company United Therapeutics noted, the first study participants will be six patients. The trials will involve kidney patients aged 55-70 who cannot undergo routine renal transplant surgery due to various health issues. They will be tracked for serious adverse events, infectious processes, and evidence of kidney affliction. This will involve observation for the first six weeks and then inclusion in a lifetime continuous follow-up program.

The inaugural transplant of a pig kidney into a human: Implications for the future

The test will measure effectiveness through the number of participants. As well as transplanted kidneys, which survive the operation’s procedure, and the duration. It will monitor the efficiency of the kidneys in filtering blood and note alterations in the participant’s overall life quality.

The FDA has implemented a patient pause rule to reduce risk, Fishman claims. A committee that oversees will analyze the efficacy data for the first six participants before determining if the clinical trials will include up to 50 additional participants.

Recent Innovations in Genetic Engineering

The chances of organ rejection have been decreased by altering certain genes in pigs. Thus resulting in better assimilation to the human immune system. According to Muhammad Mohiuddin, a surgeon and researcher from the University of Maryland School of Medicine in Baltimore, trials would allow researchers to pick healthier candidates. So it can replace the original compassionate-use recipients to better evaluate the safety and efficacy of the transplant surgery.

Hawthorne believes that the success of this trial will make it possible to conduct more extensive and longer-term clinical studies, says transplant surgeon Wayne Hawthorne of the University of Sydney, Australia.

Mohammed Mohiuddin, who in 2022 became the first person to perform a pig heart transplant on a living human, says that securing an FDA greenlight is more difficult with organs such as the heart. However, he claims to be in the process of submitting a request to the FDA to commence clinical trials.

As stated by Fishman, who has consulted both United Therapeutics and eGenesis on microbiology, another company, eGenesis, located in Cambridge, Massachusetts, has also applied for permission from the FDA to initiate a xenotransplant trial.

Looking Ahead

Pig organ transplant trials have the possibility of success, there would be a monumental change in organ transplantation as it would be humane. Additionally, it is also affordable for patients suffering from kidney failure. Both the medical field and the patients themselves have their attention focused on the results. They also expect that the tried new method will bring some valuable progress in organ failure treatment.