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This is an investigational cell-free biologic therapy consisting of exosomes derived from umbilical cord-derived mesenchymal stem cells (UC-MSC-derived exosomes). Developed by the Research Institute for Gastroenterology and Liver Diseases (RIGLD) in Iran, it is currently being evaluated in a Phase IIa clinical trial (NCT05871463) for the treatment of decompensated liver cirrhosis. The therapy aims to provide a safer, cell-free alternative to direct MSC transplantation by utilizing nano-sized extracellular vesicles secreted by stem cells. Its biological mechanism involves paracrine signaling that targets liver fibrosis by inhibiting the TGF-β/Smad signaling pathway, reducing collagen deposition, modulating hepatic stellate cell activity, and reversing epithelial-to-mesenchymal transition (EMT).
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