Overview
- Pol Med Tech announced on Monday that it has agreements with Hokkaido University Hospital and Shonan Kamakura General Hospital and plans to file a trial plan with the PMDA by the end of fiscal 2026 with a target start in early 2028.
- The company will use cloned donor pigs made from US‑sourced cells that carry 10 genetic edits intended to reduce immune rejection and plans to scale production to about 100 donor pigs per year by 2027.
- Trials will run at each hospital with only a few patients chosen from people in their 50s–60s who need dialysis or transplant, have no severe comorbidities, and lack living donors as eligibility criteria.
- The trial design prioritizes safety by locating pig‑procurement facilities on or next to hospital grounds to cut organ handling time and by using stronger immunosuppression with close infection and rejection monitoring.
- The move builds on US and Chinese experimental transplants including a US case reported dialysis‑free for 31 weeks as of June 28, 2026, while Japanese regulators, biosafety reviewers, ethicists and patient groups will shape whether the program proceeds and how it could expand toward possible approval around 2029.