Key points from article :
Rinri Therapeutics, a University of Sheffield spinout company focused on regenerative treatments for hearing loss, has received approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to begin its first-in-human clinical trial. The trial will test Rincell-1, an innovative therapy using otic neural progenitor cells designed to regenerate damaged auditory neurons—offering hope to people with sensorineural hearing loss (SNHL), particularly where the cochlear nerve is compromised and current solutions like cochlear implants have limited effect.
The Phase I/IIa trial, expected to produce proof-of-concept data within 12 months, will recruit 20 patients across three major hearing centres in the UK. Participants include individuals with either age-related hearing loss (presbycusis) or auditory neuropathy spectrum disorder (ANSD). Half the patients in each group will receive Rincell-1 during their cochlear implant surgery, while the others will undergo standard implantation alone, enabling comparison between the two approaches.
Key trial outcomes will focus on safety, neural health, and speech perception. Researchers will use telemetry from Advanced Bionics' AIM™ cochlear monitoring system and patient-reported outcomes to assess how effectively Rincell-1 supports nerve regeneration. Importantly, the cell therapy is delivered during standard cochlear implant surgery using a recently developed technique, streamlining its potential clinical adoption.
Professor Marcelo Rivolta, founder and Chief Scientific Officer at Rinri, emphasized the years of work that have gone into developing Rincell-1, noting its ability to repair inner ear neural structures in preclinical models. CEO Simon Chandler and Chief Medical Officer Professor Doug Hartley also highlighted the urgent need for effective therapies for neural hearing loss and the hope this trial brings to patients and clinicians alike. The trial represents a significant step toward a regenerative solution for a major cause of deafness.
