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

Area of Science:

• Neuroscience
• Otolaryngology
• Regenerative Medicine

Background:

• Sensorineural hearing loss is a prevalent, debilitating condition with limited pharmacologic treatments.
• The complex molecular basis of hearing loss challenges traditional small molecule interventions.
• Extracellular vesicles (EVs) are emerging as a potential therapeutic avenue in neurotology.

Purpose of the Study:

• To review the potential of extracellular vesicles (EVs) as a therapeutic strategy for sensorineural hearing loss.
• To explore the role of inflammation in hearing loss and its implications for cochlear implantation.
• To discuss the manufacturing and regulatory considerations for developing EVs as advanced therapy medicinal products for inner ear applications.

Main Methods:

• A narrative literature review was conducted.
• The review focused on the application of extracellular vesicles in neurotology.
• The role of inflammation in hearing loss and cochlear implantation was examined.

Main Results:

• Extracellular vesicles can modulate diverse pathologic and physiologic pathways relevant to inner ear disorders.
• GMP-manufactured EVs are suitable for human inner ear applications.
• EVs present a potential therapeutic option for inflammatory inner ear conditions, including those related to cochlear implantation.

Conclusions:

• Novel therapeutics like extracellular vesicles offer a promising approach to address complex inner ear injuries.
• EVs can modulate critical pathways such as inflammation, stress, and apoptosis in the inner ear.
• Addressing manufacturing and regulatory challenges is crucial for the clinical translation of EVs for inner ear therapy.