First-in-human trial approved for Rincell-1 therapy to regenerate damaged auditory neurons
The trial will measure safety and detect significant changes in neural health, as measured by telemetry from the Sonova-owned outfit Advanced Bionics’ cochlear implant monitoring AIMTM system, alongside a range of speech perception measures and patient-reported outcomes. Rincell-1 will be delivered to the cochlea during cochlear implant surgery via a novel extension of the current procedure.

© Getty images - Rasi Bhadramani
Rinri Therapeutics has received approval from the UK's Medicine and Healthcare products Regulatory Agency (MHRA) to begin its first-in-human clinical trial, a major step towards transforming the treatment of sensorineural hearing loss with a regenerative cell therapy.
Rincell-1, the therapy developed by this leading University of Sheffield spin-out company, has been designed to regenerate damaged auditory neurons, for which no treatment currently exists. Taking place at three leading hearing research centres in the UK, the randomised open-label trial will involve 20 patients undergoing cochlear implantation for hearing loss, 10 with postsynaptic auditory neuropathy spectrum disorder (ANSD), and 10 with severe-to-profound age-related hearing loss (presbycusis). Within each group, patients will be randomly assigned to receive a single dose of Rincell-1 in addition to cochlear implantation or cochlear implantation alone.
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