Pol Med Tech and its partner hospitals plan to conduct Japan's first clinical trials transplanting genetically modified pig kidneys into patients with severe kidney failure [1].

This initiative seeks to reduce the reliance of patients on dialysis and establish a foundation for future surgeries to address the critical shortage of human donor organs [1, 2, 3].

The venture company, which originated from Meiji University, will collaborate with Hokkaido University Hospital and Tokushukai Shonan Kamakura General Hospital to execute the trials [1, 2]. While some reports suggest clinical research could begin as early as autumn 2025 or trials in 2027, the primary plan targets 2028 for the domestic clinical trials [1, 4, 5].

Xenotransplantation, the process of transplanting organs between different species, has seen limited application in the U.S. to date. In those cases, four transplants were performed [1]. One patient survived for 271 days without the need for dialysis [1]. Other data indicates the longest period a transplanted pig kidney functioned in a U.S. patient was nine months [4].

To prevent the human immune system from rejecting the animal organ, researchers use genetically modified pigs. These modifications remove specific pig genes and add human genes to make the kidneys more compatible with the human body [2, 3].

The project aims to provide a viable alternative for those on transplant waiting lists, who often face years of uncertainty, or deteriorating health, while awaiting a compatible human match [1, 3].

Japan's first clinical trials transplanting genetically modified pig kidneys into patients with severe kidney failure.

The move toward xenotransplantation in Japan represents a significant shift in addressing chronic organ shortages. By leveraging genetic engineering to bypass immune rejection, the medical community is attempting to move from temporary dialysis support to permanent biological solutions. If successful, these trials could validate a scalable model for organ replacement that reduces the dependency on the limited pool of human donors.