Clinical Trial Protocol for Porcine Islet Xenotransplantation in South Korea.

ABSTRACT:

Backgruound

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 Ministr

SUBMITTER: Kim BJ 

PROVIDER: S-EPMC11621658 | biostudies-literature | 2024 Nov

REPOSITORIES: biostudies-literature