Japan to Trial Pig-to-Human Kidney Transplants from 2028

Japanese biotech startup PorMedTec has announced plans to conduct clinical trials for pig-to-human kidney transplants at two hospitals in Japan starting in 2028. The move is expected to provide a solution to the chronic shortage of donor organs, which has long been a major challenge in the country. In an announcement on Monday, PorMedTec stated the clinical trials will be carried out at Hokkaido University Hospital in Sapporo and Shonan Kamakura General Hospital in Kanagawa Prefecture. The company, a spin-off from Meiji University, breeds cloned pigs using genetically engineered pig cells developed by American biotech firm eGenesis. Kidneys from these pigs will be harvested for transplantation into patients. Cross-species transplantation, or xenotransplantation, is seen as a potential solution to the scarcity of donor organs in various countries, including Japan. PorMedTec is targeting production and marketing approval once the safety of the procedure is proven through clinical trials. The pigs developed by eGenesis have undergone 69 genetic modifications to suppress the risk of immune system rejection and reduce the likelihood of virus transmission from pigs to humans. To date, four clinical trials using these pig kidneys have been conducted in the United States. Results showed that transplant patients did not require dialysis for up to approximately nine months, the longest period recorded in such trials. The need for kidney transplants in Japan continues to rise. Currently, more than 300,000 people undergo dialysis due to kidney failure, while around 15,000 patients remain on the waiting list for a kidney donor. Meanwhile, the number of kidney transplants from brain-dead donors stands at only about 200 cases per year, according to the Japan Organ Transplant Network, highlighting the vast gap between demand and organ availability. The Japanese government has included cross-species transplantation as a priority area in its public-private investment roadmap announced earlier this month. The government hopes to build domestic technology and production systems so the technology can be widely implemented soon. ‘We will continue working to develop cross-species transplantation into a beneficial medical technology,’ said PorMedTec head and Meiji University professor Hiroshi Nagashima.