Japan plans to test pig kidney transplants for humans

PorMedTec, a Japanese biotechnology startup, on June 29 announced plans for a clinical trial to transplant pig kidneys into human bodies at two domestic hospitals, expected as early as 2028, according to The Japan Times.

The US and China are currently the leading countries in the field of xenotransplantation, a method of using animal organs to treat humans. To date, these two countries have recorded a total of 8 pig-to-human kidney transplants. Among them, a case of kidney failure in the US maintained life without hemodialysis for 38 weeks before receiving an organ from a donor.

PorMedTec was separated from Meiji University, currently imports gene-edited pig cells developed by the American biotechnology company eGenesis, then cultivates cloned pigs for organ transplant purposes in Japan.

Theo The Mainichithe startup has reached an agreement with Hokkaido University Hospital, Sapporo City, and Shonan Kamakura General Hospital, Kamakura City, Kanagawa Prefecture, to begin preparations for trials. Surgical facilities to remove organs from donated pigs will be built right on the campus or in the land adjacent to the hospital. This helps the organs to be transported immediately to the human operating room, ensuring the best quality is maintained.

The clinical trial plan will be submitted to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) as early as the end of fiscal 2026. Each hospital plans to conduct a few cases to evaluate both the safety and effectiveness of the method. One criterion for evaluating effectiveness is that the patient is free of hemodialysis for at least 24 weeks.

Eligible participants are expected to be patients in their 50s and 60s with chronic kidney failure who require dialysis or an organ transplant but are unlikely to receive a kidney donation from a relative or other source, and do not have serious complications such as heart disease. The patient’s overall health condition will also be carefully considered, as this method requires the use of stronger immunosuppressive drugs than conventional organ transplants.

Organ donor pigs will be created using cloning technology from imported pig cells from an American biotechnology company, which has clinical experience in this field. Ten genes in these cells were edited to reduce the risk of immune rejection. As of June 28, a patient who received a kidney transplant in November 2025 from pigs provided by this American company has lived healthily without needing dialysis for 31 weeks.

PorMedTec plans to establish a system capable of producing 100 donor pigs per year by 2027. If the tests go well, the company plans to apply for government approval of the process as a regenerative medicine product in 2029, and move forward with extensive cooperation with domestic medical facilities to deploy the technique.

Japan currently has more than 300,000 people on dialysis due to kidney diseases and about 15,000 people on the kidney transplant waiting list. Meanwhile, according to data from the Japan Organ Transplant Network, the number of organ transplants from brain-dead donors only reaches about 200 per year.

In that context, the Japanese government has included xenotransplantation in the list of one of the key areas in the public-private investment roadmap announced earlier this month. The Government expects to soon master domestic technologies and production systems to bring this solution into practical application in the shortest time.

“In the immediate future, we want to take advantage of the achievements of the world’s leading corporations in the US, thereby building the foundation for bringing xenotransplantation into practical application in Japan,” shared Mr. Hiroshi Nagashima, Director of PorMedTec and a professor at Meiji University.