NCT07032038

First In Human Randomised Trial of Rincell-1 in Adults With a Cochlear Implant

First In Human, Multi-Center Open-Label Randomized Trial to Assess Safety of Rincell-1 Otic Neural Progenitor Cell-Based Therapy and Standard Care vs Standard Care Alone, in Adults With Neural Hearing Loss Eligible for Cochlear Implantation

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Rinri Therapeutics · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The proposed study is a Phase I/IIa, randomized, open-label, multi-center, First In Human trial of an Advanced Therapy Investigational Medicinal Product (ATIMP) to investigate the safety of Rincell-1 as a treatment for neural hearing loss. All participants will be recruited from adult patients who have been assessed as being eligible to receive a unilateral cochlear implant (CI) on the National Health Service at a UK CI Centre. Trial participants will meet UK NICE criteria for cochlear implantation, and will be: * Cohort 1: Patients with hearing loss due to bilateral progressive presbycusis (aged-related hearing loss) * Cohort 2: Patients with postsynaptic Auditory Neuropathy Participants will be randomized (3:2), by cohort, to receive either Standard Care unilateral CI plus a single dose of Rincell-1 administered at the same time as CI surgery, or Standard Care unilateral CI alone. Each cohort will have up to a total of 10 participants: 6 in the CI+Rincell-1 arm, and 4 in the standard care CI arm. A total of up to 12 participants across the two cohorts will be dosed with Rincell-1. Subjects will be followed up to 52 weeks post-implantation.

Conditions

• Sensorineural Hearing Loss
• Presbyacusis
• Auditory Neuropathy

Interventions

Type	Name	Description
DRUG	Otic neural progenitors	Advanced Cell Therapy - tissue engineered product
DEVICE	cochlear implantation	cochlear implant

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-11-01
• Completion: 2028-02-01
• First posted: 2025-06-22
• Last updated: 2026-03-11

Locations

3 sites across 1 country: United Kingdom