Kim Jong-Min, Park Chung-Gyu
Transplantation Research Institute, Medical Research Center, Seoul National University College of Medicine, Seoul, Korea.
Department of Animal Health and Welfare, Cheongju University College of Health and Medical Sciences, Cheongju, Korea.
Clin Transplant Res. 2025 Mar 31;39(1):1-11. doi: 10.4285/ctr.24.0046. Epub 2025 Feb 10.
Pancreatic islet transplantation represents the optimal treatment for severe hypoglycemia, a serious complication experienced by patients with long-term type 1 diabetes who are undergoing insulin therapy. However, the limited availability of donor organs restricts its widespread use. Porcine pancreatic islets could offer a viable alternative to address this organ shortage. For successful pancreatic islet xenotransplantation using porcine pancreatic islets, efficacy and safety must first be demonstrated in pig-to-nonhuman primate (NHP) preclinical studies, as outlined in the consensus statement of the International Xenotransplantation Association. Our group has achieved long-term survival of wild-type porcine islet grafts in immunosuppressed NHPs by employing two immunosuppressive protocols: one based on CD40-CD40L blockade and another utilizing clinically available immunosuppressants. A clinical trial for pancreatic islet xenotransplantation, following the latter protocol, has received approval from the Korean Ministry of Food and Drug Safety (MFDS). This review aims to highlight the results of clinical trials involving porcine islet xenotransplantation to date, along with the age-specific and other characteristics of the porcine islets used in these trials and the preclinical NHP studies that support them. It offers insights into the perspectives around the first clinical islet xenotransplantation approved by the Korean MFDS, emphasizing improved long-term graft survival.
胰岛移植是严重低血糖症的最佳治疗方法，严重低血糖是长期接受胰岛素治疗的1型糖尿病患者所经历的一种严重并发症。然而，供体器官的有限供应限制了其广泛应用。猪胰岛可为解决这种器官短缺问题提供一种可行的替代方案。正如国际异种移植协会的共识声明中所概述的，要使用猪胰岛成功进行胰岛异种移植，必须首先在猪到非人灵长类动物（NHP）的临床前研究中证明其有效性和安全性。我们的研究小组通过采用两种免疫抑制方案，使野生型猪胰岛移植物在免疫抑制的NHP中实现了长期存活：一种基于CD40-CD40L阻断，另一种使用临床可用的免疫抑制剂。遵循后一种方案的胰岛异种移植临床试验已获得韩国食品药品安全部（MFDS）的批准。本综述旨在突出迄今为止涉及猪胰岛异种移植的临床试验结果，以及这些试验中使用的猪胰岛的年龄特异性和其他特征，以及支持这些试验的临床前NHP研究。它提供了对韩国MFDS批准的首例临床胰岛异种移植相关观点的见解，强调了提高移植物长期存活率。
