Company-Sponsored Clinical Trial to Begin for Japan's First Genetically Modified Pig Kidney Transplant

Shonan Kamakura General Hospital Kidney Transplant Procedure (Tokushukai Medical Corporation)

Shonan Kamakura General Hospital (Kamakura City, Kanagawa Prefecture; Director: Shuzo Kobayashi, Vice Chairman of Tokushukai Medical Corporation) has begun preparations in collaboration with Por-Med-Tech Inc. and Hokkaido University to conduct a company-sponsored clinical trial for xenotransplantation using genetically modified pigs (pig kidney transplant), a first in Japan.

This clinical trial aims to establish a new treatment method for patients with severe kidney failure, with the goal of commencing trials in 2028 after consultations with relevant authorities.

Role of Shonan Kamakura General Hospital

As a core hospital of the Tokushukai Group, Shonan Kamakura General Hospital provides advanced acute care and has been broadly involved in kidney disease treatment, dialysis, and organ transplantation.

In this clinical trial, the hospital will primarily be responsible for the following items, playing a central role in the clinical application of xenotransplantation, a first in Japan:

Establishing the clinical trial system

Establishing surgical techniques

Perioperative management by a multidisciplinary team

Building a medical model for future nationwide expansion

Background of Shonan Kamakura General Hospital's Participation

Shonan Kamakura General Hospital has one of the leading track records in kidney transplantation in Japan. In 2023, it performed 37 kidney transplants, ranking first in Kanagawa Prefecture and seventh nationwide in total kidney transplants, and fifth nationwide in living donor kidney transplants (*1). The hospital also has extensive experience in ABO blood type incompatible kidney transplants, providing advanced kidney transplant medical care. However, in Japan, while there are approximately 340,000 dialysis patients (*2), there is a chronic shortage of donors for transplantation, forcing many patients to continue dialysis treatment for extended periods. Xenotransplantation using genetically modified pigs is expected to be a new option to address these challenges.

In this clinical trial, not only surgical techniques but also an environment that allows for close collaboration between research and development and clinical practice is crucial.

Our hospital is adjacent to Shonan Health Innovation Park (Shonan iPark), a research and development hub in the life sciences field, and houses the Shonan Research Institute for Innovative Medicine (sRIIM), a dedicated research laboratory for the hospital. This environment allows us to promote "translational research," which rapidly connects findings from basic research to clinical applications.

Furthermore, as a core hospital providing advanced acute care, our hospital has an advanced medical system where multiple disciplines, including nephrology, urology, transplant medicine, pathology, and infection control, collaborate. Our environment, which combines research infrastructure with clinical capabilities, was recognized, leading to our participation as one of the clinical trial facilities.

*1 Source: Japan Society for Clinical Renal Transplantation & The Transplantation Society of Japan, "Report on Clinical Renal Transplant Registration Statistics (2024) - Summary Report of 2023 Cases and Follow-up Results." The hospital performed 37 kidney transplants in 2023. *2 Source: Japan Society for Dialysis Therapy, "Current Status of Chronic Dialysis Therapy in Japan (as of December 31, 2024)." The number of chronic dialysis patients as of the end of 2024 was 337,414.

Future Outlook

For patients awaiting kidney transplants, the shortage of donor organs has been a long-standing and difficult challenge to solve. Xenotransplantation is a technology with the potential to significantly change transplant medicine in the future. Shonan Kamakura General Hospital will proceed with research and development based on scientific evidence, prioritizing safety, and strive to provide new treatment options for patients with severe kidney failure.

Hospital Director's Comment

Shuzo Kobayashi (Vice Chairman, Tokushukai Medical Corporation; Director, Shonan Kamakura General Hospital)

"There are many patients nationwide who continue dialysis treatment while waiting for a kidney transplant. This project holds the potential to bring new hope to such patients and represents a major challenge in Japanese transplant medicine. Our hospital will collaborate with Hokkaido University, Por-Med-Tech Inc., and other related organizations, prioritizing safety and ethics, to achieve the success of this clinical trial."

Invitation to Press Conference

A press conference for media representatives will be held on July 21 (Tue) at 4:00 PM regarding this clinical trial.

Those wishing to attend are requested to contact the Public Relations Office via email or phone by noon on July 21 (Tue) with the following information:

(1) Your company name

(2) Name of contact person

(3) Contact information for the person in charge

(4) Number of attendees (please respond only for those attending)

(5) Equipment to be brought (still camera, voice recorder, etc.)

(6) Number of parking spaces required *Please respond only if arriving by car.

*If attending the interview on the day is difficult due to circumstances, we will provide official materials.

[Press Conference Overview]

Date and Time: July 21, 2026 (Tue) 4:00 PM onwards

Location: Shonan Kamakura General Hospital, Building D (Advanced Medical Center Building), 4th Floor, Training Center A

1370-1 Okamoto, Kamakura City, Kanagawa Prefecture, 247-8533

Speakers:

Name

Position/Affiliation

Presentation Topic

Shuzo Kobayashi

Vice Chairman, Tokushukai Medical Corporation

Director, Shonan Kamakura General Hospital

Significance and Background of Conducting This Project at Our Hospital

Sumie Hidaka

Shonan Kamakura General Hospital

Director, Comprehensive Kidney Disease Medical Center

Follow-up on Immunoinfection

Kazunari Tanabe

Shonan Kamakura General Hospital

Director, Kidney Transplant and Robotic Surgery Center

Transplant Surgery

Hiroshi Nagashima

Por-Med-Tech Inc.

Representative Director and Chief Scientist

Cloning and Modification

Genjiro Miwa

Por-Med-Tech Inc.

Representative Director and President

Company Overview

Future Schedule

Inquiries Regarding Coverage

Tokushukai Medical Corporation Shonan Kamakura General Hospital

Public Relations Office

E-mail: kouhou@shonankamakura.or.jp

TEL: 0467-46-9947 (Direct line to Public Relations Office, Weekdays 8:30 AM - 5:00 PM)