KDA
- Current
- Browse
- Collections
-
For contributors
- For Authors
- Instructions for authors
- Article processing charge
- For Reviewers
- Instructions for reviewers
- How to become a reviewer
- Best reviewers
- For Readers
- Readership
- Subscription
- Permission guidelines
- About
- Editorial policy
Search
- Page Path
- HOME > Search
Original Article
- Others
- Clinical Trial Protocol for Porcine Islet Xenotransplantation in South Korea
- Byung-Joon Kim, Jun-Seop Shin, Byoung-Hoon Min, Jong-Min Kim, Chung-Gyu Park, Hee-Jung Kang, Eung Soo Hwang, Won-Woo Lee, Jung-Sik Kim, Hyun Je Kim, Iov Kwon, Jae Sung Kim, Geun Soo Kim, Joonho Moon, Du Yeon Shin, Bumrae Cho, Heung-Mo Yang, Sung Joo Kim, Kwang-Won Kim
- Diabetes Metab J. 2024;48(6):1160-1168. Published online May 21, 2024
- DOI: https://doi.org/10.4093/dmj.2023.0260
- 10,831 View
- 278 Download
- 6 Web of Science
- 8 Crossref
-
Abstract
PDF
Supplementary Material
PubReader 
ePub - Background
Islet transplantation holds promise for treating selected type 1 diabetes mellitus patients, yet the scarcity of human donor organs impedes widespread adoption. Porcine islets, deemed a viable alternative, recently demonstrated successful longterm survival without zoonotic risks in a clinically relevant pig-to-non-human primate islet transplantation model. This success prompted the development of a clinical trial protocol for porcine islet xenotransplantation in humans.
Methods
A single-center, open-label clinical trial initiated by the sponsor will assess the safety and efficacy of porcine islet transplantation for diabetes patients at Gachon Hospital. The protocol received approval from the Gachon Hospital Institutional Review Board (IRB) and the Korean Ministry of Food and Drug Safety (MFDS) under the Investigational New Drug (IND) process. Two diabetic patients, experiencing inadequate glycemic control despite intensive insulin treatment and frequent hypoglycemic unawareness, will be enrolled. Participants and their family members will engage in deliberation before xenotransplantation during the screening period. Each patient will receive islets isolated from designated pathogen-free pigs. Immunosuppressants and systemic infection prophylaxis will follow the program schedule. The primary endpoint is to confirm the safety of porcine islets in patients, and the secondary endpoint is to assess whether porcine islets can reduce insulin dose and the frequency of hypoglycemic unawareness.
Conclusion
A clinical trial protocol adhering to global consensus guidelines for porcine islet xenotransplantation is presented, facilitating streamlined implementation of comparable human trials worldwide. -
Citations
Citations to this article as recorded by
- Present Advances and Emerging Challenges in Kidney Xenotransplantation
Kazuaki Yamanaka, Yoichi Kakuta, Shuji Miyagawa, Kentaro Inoue, Soichi Matsumura, Shota Fukae, Masataka Kawamura, Shigeaki Nakazawa, Kenichi Kobayashi, Susumu Kageyama, Norio Nonomura
Journal of Clinical Medicine.2026; 15(5): 1692. CrossRef - Stammzell- und Betazell-Transplantation bei Diabetes mellitus
Barbara Ludwig
Diabetologie und Stoffwechsel.2026; 21(02): 112. CrossRef - Closed-Loop Extracorporeal Vascular Cleaning by Staged Chemical Dissolution
Ilia Toli
Cureus.2026;[Epub] CrossRef - Co-transplantation of pancreatic islets with adipose-derived mesenchymal stem cells in vascularized kidney ECM scaffolds to restore type 1 diabetes mellitus
Minji Choi, Prayas Chakma Shanto, Md Abdullah Al Fahad, Sang-ho Bae, Byong-Taek Lee
Bioactive Materials.2026; 65: 268. CrossRef - An electronic medical record-based frailty index as a locally constructed composite risk score associated with septic shock and mortality in older patients with community-acquired pneumonia
Sha Huang, Yan Guo, Qiying Zhou, Xiaoli Wu, Yan Wang, Xiaoyan Chen
Geriatric Nursing.2026; 73: 104259. CrossRef - Allogeneic Islet Transplantation: Chronicle of a Death Foretold?
Thierry Berney, Olivier Thaunat, Ekaterine Berishvili
Transplant International.2025;[Epub] CrossRef - Donor pigs for clinical islet xenotransplantation: Review and future directions
Shinichi Matsumoto, Sadaki Asari, Yoshihide Nanno, Hiroyuki Nakamura, Taisuke Okawa, Takumi Fukumoto
Cell Transplantation.2025;[Epub] CrossRef - Harmonizing International Regulatory Standards for Porcine Endogenous Retrovirus (PERV) Screening in Genetically Modified Porcine Donors for First‐in‐Human Pancreatic Islet Xenotransplantation
Muhammad Umer Suleman, Muhammad Mursaleen, Umer Khalil
Xenotransplantation.2025;[Epub] CrossRef
- Present Advances and Emerging Challenges in Kidney Xenotransplantation
First
Prev
