GenNBio's study OKed to transplant pig pancreatic islet into diabetic patients – KBR

GenNBio said it obtained approval from the Ministry of Food and Drug Safety (MFDS) for a phase 1 clinical trial to test transplanting sterile pig pancreatic islets into diabetic patients.
According to the company, xenogenic pancreatic islet transplantation is a low-burden treatment that can be performed even with a simple procedure.
"Global researchers expect that the xeno-pancreatic islet transplantation will be the first to be commercialized worldwide among xenotransplantations because the burden and risk to the patient are lower than other transplants," the company said. "Demand is high at home and abroad as it is a fundamental treatment for type 1 diabetes patients who have difficulty controlling blood sugar even with insulin treatment."
The company also said the approval marks the world's first xeno-pancreatic islet transplantation clinical trial that complies with the standards of international organizations such as the World Health Organization (WHO) and the International Xenotransplantation Association (IXA).
In the previous non-clinical trial, the company confirmed that a primate diabetes model transplanted with germ-free pig pancreatic islets showed a significant reduction in insulin requirements compared to that before transplantation, meeting the entry requirements for international clinical trials in terms of efficacy.
GenNBio also confirmed that its study meets the standards presented by international organizations and the domestic safety standards established through the consultation of the Korean Society of Infectious Diseases.
With the trial approval, GenNBio and Gachon University Gil Medical Center will carry out the project together, with researchers who were part of the Seoul National University's Bioxenogeneic Organ Development Project also collaborating.
GenNBio will manufacture the sterile pig pancreatic islets into a cell therapy product that can be administered to patients at its heterogeneous pancreatic islet cell therapy manufacturing plant in Gil Hospital and provide it to the hospital.
When the hospital initiates the clinical trial, xenogeneic pancreatic islets from sterile pigs will be transplanted into two patients with type 1 diabetes, and the hospital will follow up for two years to confirm the safety and efficacy of the transplant.
"The company is pleased that xeno-pancreatic islet transplantation, a new treatment of advanced regenerative medicine, has finally entered clinical trials after careful supplementation," GenNBio CEO Kim Sung-joo said. "By taking this clinical trial as a cornerstone, we will contribute to Korea's international competitiveness in the xenotransplantation field."
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