First-in-human trial for regenerative cell therapy for sensorineural hearing loss approved
The study is powered to measure safety and detect significant changes in neural health, as measured by telemetry from Advanced Bionics’ cochlear implant monitoring AIM system
Rinri Therapeutics, a spinout company from the University of Sheffield dedicated to transforming sensorineural hearing loss (SNHL) with regenerative cell therapy, has received approval to begin its first-in-human clinical trial.
The UK’s Medicine and Healthcare products Regulatory Agency (MHRA) approved Rincell-1, a first-in-class otic neural progenitor cell therapy, for the first-in-human Phase I/IIa trial (1). Clinical proof-of-concept data is expected within 12 months of trial initiation.
While current standard-of-care treatments like cochlear implants help manage the symptoms of sensorineural hearing loss, their effectiveness depends on the integrity of the cochlear nerve. Rincell-1 has been designed to regenerate damaged auditory neurons, for which no treatment currently exists, bringing the potential to transform the lives of people with neural hearing loss and to play a significant role in healthy ageing.
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.
The study is powered to measure safety and detect significant changes in neural health, as measured by telemetry from Advanced Bionics’ cochlear implant monitoring AIM 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, as previously published in 2024 (2).
References:
1 First in human, multi-centre open-label randomised trial to assess the safety of Rincell-1 otic neural progenitor cell-based therapy in addition to standard care, compared with standard care alone, in participants with presbycusis or postsynaptic auditory neuropathy who meet UK guidelines for Cochlear Implantation. IRAS Ref: 1006992. Clin trials gov NCT07032038
2 Novel procedure for cell delivery in Rinri Therapeutics’ first clinical trial described in peer-reviewed publication