Clinical Trial Protocol for Porcine Islet Xenotransplantation in South Korea
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 clin...
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| Format: | Article |
| Language: | English |
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Korean Diabetes Association
2024-11-01
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| Series: | Diabetes & Metabolism Journal |
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| Online Access: | http://e-dmj.org/upload/pdf/dmj-2023-0260.pdf |
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| author | 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 |
| author_facet | 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 |
| author_sort | Byung-Joon Kim |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-49fbc8ac31a44224b6c25d5a1279dced |
| institution | OA Journals |
| issn | 2233-6079 2233-6087 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | Korean Diabetes Association |
| record_format | Article |
| series | Diabetes & Metabolism Journal |
| spelling | doaj-art-49fbc8ac31a44224b6c25d5a1279dced2025-08-20T02:06:57ZengKorean Diabetes AssociationDiabetes & Metabolism Journal2233-60792233-60872024-11-014861160116810.4093/dmj.2023.02602849Clinical Trial Protocol for Porcine Islet Xenotransplantation in South KoreaByung-Joon Kim0Jun-Seop Shin1Byoung-Hoon Min2Jong-Min Kim3Chung-Gyu Park4Hee-Jung Kang5Eung Soo Hwang6Won-Woo Lee7Jung-Sik Kim8Hyun Je Kim9Iov Kwon10Jae Sung Kim11Geun Soo Kim12Joonho Moon13Du Yeon Shin14Bumrae Cho15Heung-Mo Yang16Sung Joo Kim17Kwang-Won Kim18 Department of Internal Medicine, Gachon University Gil Medical Center, Gachon University College of Medicine, Incheon, Korea Tascom, Co. Ltd., Anyang, Korea Tascom, Co. Ltd., Anyang, Korea Department of Animal Health, Cheongju University College of Health and Medical Sciences, Cheongju, Korea Transplantation Research Institute, Seoul National University College of Medicine, Seoul, Korea Department of Laboratory Medicine, College of Medicine, Hallym University, Anyang, Korea Department of Microbiology and Immunology, Seoul National University College of Medicine, Seoul, Korea Department of Microbiology and Immunology, Seoul National University College of Medicine, Seoul, Korea Department of Microbiology and Immunology, Seoul National University College of Medicine, Seoul, Korea Department of Microbiology and Immunology, Seoul National University College of Medicine, Seoul, Korea Department of Medical Education, Ewha Womans University College of Medicine, Seoul, Korea GenNBio Inc., Seongnam, Korea GenNBio Inc., Seongnam, Korea GenNBio Inc., Seongnam, Korea GenNBio Inc., Seongnam, Korea GenNBio Inc., Seongnam, Korea GenNBio Inc., Seongnam, Korea GenNBio Inc., Seongnam, Korea Department of Internal Medicine, Gachon University Gil Medical Center, Gachon University College of Medicine, Incheon, KoreaBackground 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.http://e-dmj.org/upload/pdf/dmj-2023-0260.pdfclinical trialdiabetes mellitusislets of langerhansswinetransplantation |
| spellingShingle | 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 Clinical Trial Protocol for Porcine Islet Xenotransplantation in South Korea Diabetes & Metabolism Journal clinical trial diabetes mellitus islets of langerhans swine transplantation |
| title | Clinical Trial Protocol for Porcine Islet Xenotransplantation in South Korea |
| title_full | Clinical Trial Protocol for Porcine Islet Xenotransplantation in South Korea |
| title_fullStr | Clinical Trial Protocol for Porcine Islet Xenotransplantation in South Korea |
| title_full_unstemmed | Clinical Trial Protocol for Porcine Islet Xenotransplantation in South Korea |
| title_short | Clinical Trial Protocol for Porcine Islet Xenotransplantation in South Korea |
| title_sort | clinical trial protocol for porcine islet xenotransplantation in south korea |
| topic | clinical trial diabetes mellitus islets of langerhans swine transplantation |
| url | http://e-dmj.org/upload/pdf/dmj-2023-0260.pdf |
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