Japan Aims to Make Pig Kidney Transplants Standard Procedure by 2033

Japanese biotech startup PorMedTec, founded at Meiji University, has unveiled a plan to address the shortage of donor organs. The company intends to bring surgeries transplanting genetically modified pig kidneys into humans into clinical practice.

Trial and Regulatory Approval Timeline

The project’s roadmap is divided into several key phases:

• 2028: Japan’s first clinical trials of pig-to-human kidney xenotransplantation begin.
• 2029–2030: Conditional approval from Japanese regulatory authorities is obtained.
• 2033: The surgeries become a standard medical practice, positioned as a full-fledged alternative to dialysis.

Genetic Modifications from eGenesis

To prevent immediate rejection of foreign tissue by the human immune system, researchers are using cells from U.S. biotech company eGenesis.

The pigs’ DNA is modified with 69 genetic changes:

• Immune masking: The modifications alter the organ’s tissue structure, making it biocompatible with the human body.
• Virus removal: Endogenous porcine retroviruses, which pose a potential risk to humans, are completely excised from the genome.

According to surgeons, the vascular system of these modified animals almost completely matches the anatomical structure of human blood vessels.

Practical Experience and Results in the U.S.

The technology has already proven viable in experimental surgeries in the United States. The fourth American patient to receive a modified kidney transplant survived safely without dialysis for a record 9 months (271 days). This gave them the necessary time to later receive a successful human donor organ transplant.