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This is an investigational biologic therapy consisting of aerosolized mesenchymal stem cell-derived exosomes (MSC-Exos) developed by the First Affiliated Hospital of Guangxi Medical University. It is specifically designed for the prevention and treatment of radiation-induced oral mucositis (RIOM) in patients with head and neck cancer undergoing radiotherapy. These exosomes are nanoscale extracellular vesicles (approximately 30-150 nm) containing proteins, nucleic acids, and lipids that possess immunomodulatory and tissue regenerative properties. The therapy is administered via an oral spray (aerosolization) and works by exerting anti-inflammatory effects—specifically modulating the release of pro-inflammatory mediators like TNF-α, IL-1β, and IL-6—and promoting tissue repair in the damaged oral mucosa. As a cell-free modality, it offers potential advantages over direct stem cell therapy, including enhanced stability, reduced immunogenicity, and easier storage. It is currently being evaluated in a Phase 2 randomized controlled trial.
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