MedTrace Logo

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

NCT07032038 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-12

No results posted yet for this study

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.

Conditions

  • Sensorineural Hearing Loss
  • Presbyacusis
  • Auditory Neuropathy

Interventions

DRUG

Otic neural progenitors

Advanced Cell Therapy - tissue engineered product

DEVICE

cochlear implantation

cochlear implant

Sponsors & Collaborators

Principal Investigators

  • Douglas Hartley · Rinri Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-11-30
Completion
2028-02-29

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07032038 on ClinicalTrials.gov