Japan prepares first human trial of pig kidney transplants
PorMedTec announced on Monday that it has reached a basic agreement with Hokkaido University and the Tokushukai Medical Corporation to prepare a company-sponsored clinical trial of xenotransplantation, in which organs from animals are transplanted into human patients.
The trial is expected to take place at Hokkaido University Hospital in Sapporo and Shonan Kamakura General Hospital in Kanagawa Prefecture. The company plans to finalize the trial protocol in consultation with Japanese regulators, with clinical testing targeted to begin in 2028.
PorMedTec said it aims to make pig kidney transplantation a treatment option for patients with severe kidney failure once the procedure receives regulatory approval. The company also intends to establish a manufacturing and supply network capable of providing donor pig kidneys to medical institutions across Japan.
The project uses genetically modified pigs originally developed by U.S. biotechnology company eGenesis. The donor animals have undergone 69 genetic modifications designed to reduce the risk of organ rejection and eliminate the possibility of transmitting porcine endogenous retroviruses, known as PERVs.
According to the company, eGenesis has already carried out four pig-to-human kidney transplant procedures in the United States since 2024 under authorization from the U.S. Food and Drug Administration. The longest reported period without dialysis following transplantation is 271 days.
PorMedTec reproduces the genetically modified pigs in Japan using cloning technology. Since April, pigs bred by the company have been used by surgeons to practice kidney removal and transplantation procedures in preparation for the upcoming trial.
According to the Japan Organ Transplant Network, around 300,000 people in Japan undergo dialysis, while approximately 15,000 are currently waiting for a kidney transplant.
Earlier, Qazinform News Agency reported that Fujita Health University in Aichi Prefecture announced plans to begin clinical trials for womb transplants within the next few years.
