Japan to launch first pig-to-human kidney trials at two hospitals
PorMedTec plans safety trials in Hokkaido and Kanagawa using cloned genetically modified pig kidneys, as Japan seeks new answers to its donor shortage
- Japanese biotech firm PorMedTec Co. plans to conduct the country's first human trials for pig-to-human kidney transplants, with procedures starting as early as 2028.
- The clinical trials will take place at two designated sites: Hokkaido University Hospital and Shonan Kamakura General Hospital.
- The kidneys will be sourced from cloned pigs that have been genetically modified at 69 sites to curb immune rejection and reduce infection risks.
- This xenotransplantation effort is a response to Japan's significant shortage of donor organs, with approximately 15,000 patients waiting for a kidney transplant.
Japanese biotechnology start-up PorMedTec Co. said on Monday (29 June) it intends to run the country’s first human trials involving kidneys transplanted from pigs, with the procedures planned at two Japanese hospitals as early as 2028.
The sites are Hokkaido University Hospital in Hokkaido, Japan’s northernmost prefecture, and Shonan Kamakura General Hospital in Kanagawa Prefecture, south of Tokyo.
The work falls under xenotransplantation, the use of animal organs in humans, which is seen as a possible response to the persistent shortage of donor organs.
The company, which grew out of Meiji University, aims to seek manufacturing and marketing approval if the trials confirm the procedure’s safety.
The kidneys to be used will come from cloned pigs raised in Japan using genetically modified pig cells brought in from the US start-up eGenesis.
PorMedTec plans to remove kidneys from those cloned pigs and transplant them into patients.
The pigs have been modified at 69 genetic sites to curb immune rejection, while steps have also been taken to reduce the risk of infection from pig-derived viruses.
In the United States, four clinical trials of this form of xenotransplantation have taken place so far.
In the longest case, a patient was able to stop dialysis for about nine months.
Japan has more than 300,000 patients receiving dialysis for conditions including chronic renal failure, while around 15,000 people are waiting for a kidney transplant.
By contrast, only about 200 transplants from brain-dead donors are carried out each year, according to the Japan Organ Transplant Network, which links donors and recipients.
The government has also placed xenotransplantation among the priority areas in the public-private investment initiative roadmap released this month.
The plan calls for early practical use by developing domestic technologies and establishing manufacturing systems.
Hiroshi Nagashima, a Meiji University professor and representative director of PorMedTec, said: “We hope to make efforts to ensure that xenotransplantation develops into a useful medical technology.”
[Copyright The Jiji Press, Ltd.]
