Extracellular Vesicles in Inner Ear Therapies—Pathophysiological, Manufacturing, and Clinical Considerations

Sensorineural hearing loss is a common and debilitating condition, and current pharmacologic interventions are limited by the complex molecular pathology underlying hearing loss. Extracellular vesicles (EVs) offer a potential therapeutic avenue by modulating various pathologic and physiologic pathways. They can be manufactured under GMP conditions, making them suitable for application in the human inner ear, particularly for inflammatory disorders. The review discusses the role of inflammation in hearing loss, especially in the context of cochlear implantation, and how EVs can provide a therapeutic option for complex inflammatory disorders of the inner ear. Manufacturing and regulatory issues for developing EVs as advanced therapy medicinal products (ATMPs) for inner ear use are outlined. Given the complexities of inner ear injury, novel therapeutics such as extracellular vesicles could provide a means to modulate inflammation, stress pathways and apoptosis in the inner ear.

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  Extracellular vesicles (EVs) can modulate a wide range of pathologic and physiologic pathways and can be manufactured under GMP conditions.
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  EVs derived from human vestibular schwannoma (VS) cell culture can exert differential effects on hair cells and auditory neurons.
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  Umbilical cord-derived MSC-EVs exerted immunomodulatory activity on T cells and microglial cells and significantly improved spiral ganglion neurons’ survival in vitro