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VSF1.01 + human umbilical cord mesenchymal stem cell-derived extracellular vesicles is a combination regenerative therapy developed by the Hannover Medical School (Medizinische Hochschule Hannover, MHH) for the treatment of sensorineural hearing loss. The product consists of extracellular vesicles (EVs) harvested from human umbilical cord mesenchymal stem cells (hUC-MSCs) encapsulated within a specialized thermoreversible poloxamer-based hydrogel delivery system designated as VSF1.01. The hUC-MSC-EVs function as a biologic cargo containing a complex mixture of proteins, microRNAs, and lipids that exert neuroprotective, anti-inflammatory, and anti-apoptotic effects on damaged cochlear hair cells and spiral ganglion neurons. The VSF1.01 gel is designed to be liquid at room temperature for easy intratympanic injection and solidifies into a depot at body temperature upon contact with the middle ear mucosa. This allows for the sustained release and diffusion of the vesicles through the round window membrane into the inner ear, overcoming the rapid clearance typically associated with liquid formulations.
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