Final IRB Approval Obtained... Ready to Enter Clinical Trials
Starting Clinical Trials in the First Half of This Year
[Asia Economy Reporter Myunghwan Lee] Domestic bio companies and medical professionals are launching a clinical trial to transplant pig islets into patients with severe diabetes for the first time in the world.
On the 8th, Sungkyu Kim, CEO of Zenenbio, Jungkyu Park from Seoul National University Organ Transplantation Research Institute, and Kwangwon Kim, professor at Gachon University Gil Hospital, held a press conference at the Westin Chosun Hotel in Jung-gu, Seoul, to announce the clinical trial plan for xenogeneic islet transplantation. They explained, "This xenogeneic islet transplantation clinical trial is the world's first clinical trial conducted in compliance with the standards of the World Health Organization and the International Xenotransplantation Association."
Kim Sung-joo, CEO of Zenenbio, is presenting at the "Heterologous Islet Transplantation Clinical Trial Meeting" held on the morning of the 8th. / Photo by Zenenbio
The islets (Islets of Langerhans) are endocrine cell tissues scattered throughout all parts of the pancreas, named because the clustered cells resemble small islands. The islets secrete hormones such as insulin and glucagon, which regulate blood sugar levels in the body. When the islets are damaged, insulin is not properly secreted, leading to diabetes. According to Zenenbio, the demand for islet transplantation to replace damaged islets far exceeds the actual number of transplants performed. Islet transplantation cannot be done with living donors and must be performed using organs from brain-dead donors; in most cases, the whole pancreas is transplanted first rather than the islets. Only when pancreas transplantation is deemed impossible are islets extracted from the pancreas and transplanted. Considering that only about 10% of organ transplant candidates in Korea actually receive transplants, the limitations are clear.
Research on xenotransplantation as an alternative to living islet transplantation is underway across various fields. This clinical trial will proceed with xenogeneic organ transplantation by extracting islets from mini pigs and transplanting them into diabetic patients. Xenogeneic organ transplantation refers to transplanting organs, tissues, or cells from a different species. The experiment uses mini pigs from Seoul National University Organ Transplantation Research Institute that have undergone sterilization processes to remove microorganisms that could infect humans. The research team explains that mini pigs are suitable for organ transplantation because their organ composition and size are similar to those of humans.
Previously, the Ministry of Food and Drug Safety gave final approval for Zenenbio's clinical trial plan in December last year. This was about one year and four months after the clinical trial plan was submitted in August 2021. On the 19th, the Institutional Review Board (IRB) of Gachon University Gil Hospital, where the clinical trial will be conducted, also approved the plan, completing all preparations for entering the clinical trial phase.
Previously, the Ministry of Food and Drug Safety gave final approval for Zenenbio's clinical trial plan in December last year. This was about one year and four months after the clinical trial plan was submitted in August 2021. On the 19th, the Institutional Review Board (IRB) of Gachon University Gil Hospital, where the clinical trial will be conducted, also approved the plan, completing all preparations for entering the clinical trial phase.
Zenenbio and the research team plan to begin the clinical trial in the first half of this year. Seoul National University Organ Transplantation Research Institute will produce sterile pigs free of infectious bacteria and extract the pancreas. Then, Zenenbio, which has established a xenotransplantation product manufacturing facility at Gachon University Gil Hospital, will isolate and purify pure islets from the pancreas and develop them into a cell therapy product. Gachon University Gil Hospital will transplant the purified xenogeneic islets into patients and conduct long-term follow-up to confirm immunosuppressive treatment, xenogeneic islet safety, and the effectiveness of xenotransplantation.
Park Jung-kyu, Director of the Organ Transplantation Research Institute at Seoul National University, is presenting at the "Xenogeneic Islet Transplantation Clinical Trial Meeting" held on the morning of the 8th. / Photo by Zenenbio
Jungkyu Park, director of Seoul National University Organ Transplantation Research Institute, said, "In comparing the long-term survival days of primates transplanted with pig islets, the data from the Bio-Xenotransplantation Development Project Team recorded a globally outstanding level," adding, "This clinical trial has been thoroughly prepared, including reviews by the International Xenotransplantation Association and the Ethics Committee of the International Transplantation Society, so we expect positive results."
Kwangwon Kim, professor at Gachon University Gil Hospital, said, "Despite the necessity of islet transplantation, the limitations of allogeneic transplantation are clear, making xenotransplantation the only alternative," and added, "We will cooperate organically with Zenenbio and Seoul National University Organ Transplantation Research Institute to make this clinical trial a hope for patients with type 1 diabetes for whom islet transplantation is the only option." Sungju Kim, CEO of Zenenbio, emphasized, "Since this clinical trial is prepared based on the highest safety standards, we will fully utilize Zenenbio's core research capabilities to lead the clinical trial to success."
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