First In Human Randomised Trial of Rincell-1 in Adults With a Cochlear Implant (NCT07032038) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
First In Human Randomised Trial of Rincell-1 in Adults With a Cochlear Implant
United Kingdom20 participantsStarted 2026-05
Plain-language summary
Rinri Therapeutics is conducting a clinical trial of a new cell therapy called Rincell-1. Rincell-1 is being developed to treat adults with neural hearing loss, either age related hearing loss or auditory neuropathy, who also meet criteria for a cochlear implant. The goals of this study are:
* To learn about the safety profile of Rincell-1, the procedure used to inject it and the medications given to promote the growth of the cells
* To evaluate how well Rincell-1 works by measuring changes in the function of auditory neurons.
* To understand if Rincell-1 can be easily and successfully given at the same time as cochlear implant surgery
Participants will be randomly assigned to one of two groups: one group that receives a standard care cochlear implant, and the other that will receive an injection of Rincell-1 at the same time as their standard care cochlear implant. Researchers will compare the safety of Rincell-1 in combination with a cochlear implant to a cochlear implant on its own.
Participants will take part in the trial for 52 weeks after CI surgery. During that time, they will have regular follow-ups and will take daily measurements at home of their hearing health.
Who can participate
Age range18 Years – 74 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Aged 60-74 years (inclusive) at time of consent
✓. Hearing Loss due to bilateral progressive presbycusis
✓. Approved for unilateral cochlear implantation as per UK NICE criteria (TA566)
✓. Documented threshold of ≥70dB in both ears at 1000, 2000 and 4000 Hz, and ≥50dB in both ears at 500 Hz, at time of eligibility
✓. Aged 18-74 years (inclusive) at time of consent
✓. Postsynaptic AN characterised by:
✓. Approved for unilateral cochlear implantation as per UK NICE criteria TA566 and NHS England SSC1442
✓. Capable and willing to provide written informed consent
Exclusion criteria
✕. ECochG measurements and genetic testing suggestive of synaptopathy or myelinopathy, including but not limited to: Otoferlin, CABP2, SLC17A8, KARS2, DIAPH3, GJB2, OPA1, MPZ, PMP22 or SLC52 A2 and A3 mutations.
What they're measuring
1
Frequency and severity of AEs
Timeframe: From baseline (at screening) to 52 weeks post-implantation
✕. History of significant hearing loss caused by infection or head trauma
✕. History of previous cochlear implantation, in either ear
✕. Documented hearing loss secondary to ototoxic medications
✕. Suspected or confirmed hearing loss that is wholly or partly unexplained by anatomic or physiologic abnormalities (non-organic hearing loss)
✕. Evidence of current conductive hearing loss defined as 20dB or greater average air-bone gap over three of the following frequencies: 500, 1000, 2000, 3000 or 4000 Hz
✕. History of diagnosed sudden SNHL, Ménière's disease, otosclerosis, cholesteatoma, acoustic neuroma, meningitis or confirmed/suspected autoimmune inner ear disease