R1-25: The First in Human Trial of Rincell-1
Research type
Research Study
Full title
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 ID
1006992
Contact name
Douglas Hartley
Contact email
Sponsor organisation
Rinri Therapeutics
Research summary
Hearing loss is the third leading cause of disability in adults, often due to damage to cells in the inner ear like hair cells and auditory neurons. Hearing aids and cochlear implants help those with damaged hair cells but are less effective for neural hearing loss caused by auditory neuron loss or damage.
Rincell-1 is a cell-based therapy for people with neural hearing loss, using specialised, young auditory neurons grown in the lab. Laboratory and animal studies show that Rincell-1 is safe and can restore hearing, as these cells mature into auditory neurons when put inside the ear.
This first in human clinical trial will test if Rincell-1 is safe and will provide early evidence showing if cells can grow into auditory neurons in humans, restoring healthy neural connections between the inner ear and the brain. Participants will have neural hearing loss due to age-related hearing loss or postsynaptic auditory neuropathy and will have decided with their care team to receive a cochlear implant on the NHS.
Participants will be randomly assigned to either the “Cochlear Implant” group (receiving standard care cochlear implant), or the “Cochlear Implant + Cell Therapy” group (receiving Rincell-1 together with the cochlear implant).
After surgery, participants will be closely monitored for 52 weeks with regular hospital visits for health checks, blood tests, hearing tests, and brain scans. Participants will also use an electronic tablet to take measurements from their inner ear daily at home. Participants receiving Rincell-1 will take low-dose immunosuppression medication for ten months to support cell growth.
After the trial, participants who received Rincell-1 will join a long-term follow-up study to monitor their health and quality of life until 10 years after surgery.
If effective, Rincell-1 could be a life-changing therapy for people with neural hearing loss that significantly improves hearing, speech understanding, and quality of life.
REC name
North East - York Research Ethics Committee
REC reference
25/NE/0057
Date of REC Opinion
10 Jun 2025
REC opinion
Further Information Favourable Opinion