SHEFFIELD, UNITED KINGDOM — Rinri Therapeutics, a University of Sheffield spinout pioneering regenerative therapies 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 of Rincell-1, a first-in-class otic neural progenitor cell therapy designed to treat sensorineural hearing loss (SNHL).
The Phase I/IIa trial, expected to begin imminently, will assess the safety and early signs of efficacy of Rincell-1 in regenerating auditory neurons—critical structures currently lacking any disease-modifying treatment. Proof-of-concept data is anticipated within 12 months of trial initiation.
A Novel Therapeutic Approach for Hearing Loss
While cochlear implants offer valuable support for patients with severe hearing loss, their effectiveness relies on intact auditory nerves. Rincell-1 targets the root problem for many—damaged or absent neural connections—by aiming to restore these neurons using a proprietary regenerative cell therapy.
“Approval to start our first clinical trial with Rincell-1 in hearing loss is a major milestone and recognition of the potential of our regenerative cell therapy in this area of significant unmet medical need. I’d like to thank our staff and partners for their meticulous work towards this achievement, and our investors, Boehringer Ingelheim Venture Fund, UCB Ventures and Pioneer Group, for their support.”
–Dr. Simon Chandler, CEO of Rinri Therapeutics
The randomised, open-label trial will involve 20 patients receiving cochlear implants across three leading UK hearing research centres. Participants will include 10 individuals with postsynaptic auditory neuropathy spectrum disorder (ANSD) and 10 with severe-to-profound age-related hearing loss (presbycusis). Within each group, patients will be assigned to receive either cochlear implantation alone or cochlear implantation combined with a single dose of Rincell-1.
The therapy will be delivered directly to the cochlea during the implant procedure using a novel technique published in 2024. Advanced Bionics’ AIM™ telemetry system will be used to track neural health, complemented by speech perception tests and patient-reported outcomes.
Scientific Milestone with Global Implications
Professor Marcelo Rivolta, founder and Chief Scientific Officer at Rinri Therapeutics and a professor at the University of Sheffield’s School of Biosciences, called the regulatory green light a significant scientific achievement.
“This MHRA approval is a culmination of years of rigorous scientific exploration and an unwavering belief in the potential of regenerative medicine. Our research into Rincell-1 has consistently shown its ability to target and restore the delicate neural structures of the inner ear. Now, to translate this scientific understanding into a human trial, bringing us closer to a future where we can truly restore auditory function, is profoundly rewarding for the entire team who have poured their expertise and passion into this work.”
Professor Doug Hartley, Chief Medical Officer at Rinri and Chief Investigator for the trial, emphasized the clinical importance of the study. “Working daily with individuals suffering from hearing loss, I know how devastating it can be, and the acute need for a therapy to change the disease course. It’s very exciting to be starting a clinical trial with Rincell-1, working with otologists across the world to develop this promising new approach to auditory nerve regeneration.”
If successful, the therapy could help address a global patient population currently underserved by existing solutions—more than 7 million people living with neural hearing loss for whom no approved regenerative or disease-modifying treatments exist.
Readers interested in the latest developments in hearing therapeutics can check out this excellent panel discussion from the 2025 Hearing Therapeutics Summit. Dr. Douglas Hartley of Rinri was one of the panelists:
About Rinri Therapeutics
Headquartered in Sheffield, Rinri Therapeutics is advancing a platform for regenerative hearing care through its Otic Sensory Progenitor REgenerative therapY (OSPREY™) technology. With the backing of UCB Ventures, Boehringer Ingelheim Venture Fund, and Pioneer Group, the company aims to bring forward therapies that address the root causes of hearing loss, not just its symptoms.
Source: Rinri, University of Sheffield
