Latest news with #RinriTherapeutics
Yahoo
12-07-2025
- Health
- Yahoo
Stem Cell Treatment to Reverse Hearing Loss Kicking Off in Human Patients
The first-ever human trial exploring the use of stem cell therapy to reverse hearing loss is about to be under way, after getting the go-ahead from the UK's Medicines and Healthcare products Regulatory Agency. Conducted by researchers from the University of Sheffield who formed their own spin-out company, the treatment targets sensorineural hearing loss, which is caused by physical damage to the tiny structures of the inner ear. In a nutshell, the treatment, dubbed Rincell-1, is intended to regrow damaged nerves in the cochlea and allow them to start sending signals to the brain again. "Our research into Rincell-1 has consistently shown its ability to target and restore the delicate neural structures of the inner ear," Marcelo Rivolta from the University of Sheffield, chief scientific officer at the spin-out biotech company Rinri Therapeutics, said in a statement about the work. More than a billion people worldwide are affected by some form of hearing loss, according to the WHO. Existing treatments, like cochlear implants, don't fully restore a patient's hearing, and require that the cochlea — the center piece of the inner ear that picks up sound and turns it into electrical signals — isn't significantly damaged to begin with. Key to the cochlea's function are the hair cells that line its surface, which are responsible for detecting sound. If these are severely damaged, it's game over: the hair cells are incapable of dividing to form new ones, meaning that they don't regenerate. This is called sensorineural hearing loss, and it's why your hearing inevitably worsens with age. Attempts to regrow these receptors have long been the white whale of modern medical science, and the researchers hope they've found it in Rincell-1. The treatment uses embryonic stem cells designed to grow into auditory neuron cells, which form the wiring that connects the hair cells to the brain stem. These are administered into the cochlea during the surgery to emplace the cochlear implants. Once on site, the stem cells form auditory neurons that help reconnect the out-of-commission hair cells so they can send signals again. "We are taking the approach of transplanting in cells that can become functional mature cells and restore the cytoarchitecture of the inner ear, and therefore, restore hearing," Simon Chandler, CEO of Rinri Therapeutics, told Labiotech on an episode of its "Beyond Biotech" podcast in June. The randomized trial will be conducted in the UK and will involve 20 patients who will undergo cochlear implant surgery. Half of the patients will have severe-to-profound age-related hearing loss, known as presbycusis, and the remainder will have what's known as auditory neuropathy spectrum disorder (ANSD), which is when the inner ear can detect sound but is unable to send the signals to the brain. Patients within each group will be randomly assigned to either receive a single dose of Rincell-1, or receive no dose and rely on the cochlear implant alone. On the podcast, Chandler said that the Rincell-1 treatment can be used alongside cochlear implants, but didn't rule out the possibility that it would be used on its own, too. Needless to say, it'd be a game-changer if it turns out to be effective in either scenario. More on stem cells: Diabetic Woman No Longer Needs Insulin After Single Dose of Experimental Stem Cells
Yahoo
01-07-2025
- Business
- Yahoo
UK MHRA Approval Received for First-In-Human Trial of Rincell-1, a First-In-Class Regenerative Cell Therapy for Sensorineural Hearing Loss
Rincell-1 addresses a multi $Bn global market opportunity where no disease modifying treatments currently exist Sheffield, July 01, 2025 (GLOBE NEWSWIRE) --UK MHRA Approval Received for First-In-Human Trial of Rincell-1, a First-In-Class Regenerative Cell Therapy for Sensorineural Hearing LossRincell-1 addresses a multi $Bn global market opportunity where no disease modifying treatments currently exist Sheffield, UK, July 1 2025 – Rinri Therapeutics, a world leading company focused on transforming sensorineural hearing loss (SNHL) with regenerative cell therapy, is pleased to announce the approval of its Clinical Trial Application (CTA) from the UK MHRA for its lead asset Rincell-1. Clinical proof-of-concept data from the first-in-human Phase I/IIa trial1 of Rincell-1, a first-in-class otic neural progenitor cell therapy, 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 aging. 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 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, as previously published in 2024.2 Dr Simon Chandler, CEO of Rinri Therapeutics, said, '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.' Professor Doug Hartley, CMO of Rinri Therapeutics & Chief Investigator on the trial, said, '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.' --ENDS— 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 For more information contact: Dr Simon Chandler, CEO enquiries@ About Rinri Therapeutics Rinri Therapeutics is focused on transforming sensorineural hearing loss (SNHL) with regenerative cell therapy, providing new therapeutic options for the treatment of this major global unmet medical need. It is developing first-in-class allogenic cell therapy products to treat hearing loss using its proprietary Otic Sensory Progenitor REgenerative therapY (OSPREY™) platform. There are currently no approved therapeutics for the estimated more than 7m people living with neural hearing loss globally, giving Rinri Therapeutics' cell therapies a multi-billion dollar sales potential. The company is headquartered in Sheffield, UK, and backed by UCB Ventures, Boehringer Ingelheim Venture Fund and Pioneer Group. For more information, please visit or follow us on LinkedIn. CONTACT: For more information contact: Dr Simon Chandler, CEO enquiries@
