Not yet recruitingPHASE1, PHASE2INTERVENTIONAL

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

This study is looking at a new treatment called Rincell-1 for adults with specific types of hearing loss, including age-related hearing loss or a condition called auditory neuropathy, who are also suitable for a cochlear implant. Researchers want to find out if Rincell-1 is safe and how well it works when given at the same time as a cochlear implant. Participants will either receive the standard cochlear implant surgery alone or the implant surgery with the Rincell-1 injection. The study will monitor their progress for 52 weeks after surgery to understand its potential benefits and any side effects. It's an important step in developing new ways to help people with hearing loss.

At a glance

Status

Not yet recruiting

Phase

PHASE1, PHASE2

Sponsor

Rinri Therapeutics

Enrolment target

Start

01 May 2026

Estimated completion

01 Feb 2028

Sensorineural Hearing Loss Presbyacusis Auditory Neuropathy

What is this study about?

Imagine a new approach to potentially help people who need a cochlear implant due to certain types of hearing loss. This study is exploring a new cell treatment called Rincell-1. It's designed for adults with hearing loss that comes from problems with the nerves that send sound messages to the brain. This includes age-related hearing loss, where hearing gradually worsens over time, or a condition called auditory neuropathy, where the ear can detect sounds but has trouble sending clear signals to the brain.

The main goals of this study are to check if Rincell-1 is safe when given during cochlear implant surgery, and to see if it could help improve how well the cochlear implant works by assisting the hearing nerves. Researchers also want to make sure the treatment can be given easily and successfully at the same time as the surgery. This is a "first-in-human" study, which means it’s one of the first times this new treatment is being tested in people.

Participants will be split into two groups by chance: one group will have the standard cochlear implant surgery, and the other group will have the cochlear implant surgery along with the Rincell-1 injection. The study will carefully compare both groups to understand if Rincell-1 makes a difference and if it's safe. Everyone will be followed closely for about a year to see how they are doing.

Key takeaways

It's a new cell therapy (Rincell-1) given with cochlear implants.
Aims to improve hearing for specific types of nerve-related hearing loss.
Participants will be randomly assigned to receive Rincell-1 or standard care.
The study focuses on safety and how well Rincell-1 works.
Participation lasts for about one year after surgery.
This is an early-stage study (Phase 1/2) testing a new treatment.

Who may be eligible?

This study is looking for adults who are already planning to have a cochlear implant on the NHS. You might be suitable if your hearing loss is due to either age-related changes or a specific condition called auditory neuropathy.

There are some specific requirements based on your age and the details of your hearing loss. For example, if your hearing loss is age-related, you need to be between 60 and 74 years old. If you have auditory neuropathy, you need to be between 18 and 74 years old. You also need to meet certain hearing test results and have ears healthy enough for the surgery and injection.

However, you won't be able to join if you developed profound hearing loss at an early age, or if your hearing loss is due to certain genetic conditions that affect the hearing nerves. You'll also need to be able to understand and speak English well enough for the tests and questionnaires.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 74 years old?
Are you already approved for a cochlear implant on the NHS?
Is your hearing loss due to age-related changes OR auditory neuropathy?
Do you have a healthy ear suitable for the implant and injection?
Can you understand and speak English well enough for tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be involved in this study for about a year (52 weeks) after your cochlear implant surgery. You'll be randomly put into one of two groups: either you'll receive the standard cochlear implant surgery, or you'll get the standard surgery plus the Rincell-1 injection at the same time.

During this year, you'll have several follow-up appointments at the hospital. These will involve check-ups and tests to measure your hearing and how well your cochlear implant is working. You will also be asked to take daily measurements of your hearing health at home. All these checks help the researchers understand how you are doing and if the new treatment is having an effect.

Potential risks and benefits

Taking part in this study means you could be among the first to receive a new treatment that might potentially improve hearing outcomes beyond a standard cochlear implant. However, as Rincell-1 is a new treatment, there are unknown risks, and possible side effects from the injection or the treatment itself that are not yet fully understood. As with any clinical trial, there's no guarantee that you will personally benefit from the treatment. You will be closely monitored for your safety and well-being throughout the study. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University Hospitals Birmingham
Verified postcode
Birmingham, United Kingdom
Cambridge University Hospital
Verified postcode
Cambridge, United Kingdom
Guy's and St Thomas' Trust
Verified postcode
London, United Kingdom

Common questions

What is Rincell-1?

Rincell-1 is a new cell therapy that researchers are testing to see if it can help improve hearing in people with certain types of hearing loss when combined with a cochlear implant.

Who can join this study?

This study is for adults already approved for a cochlear implant on the NHS, who have specific types of hearing loss like age-related hearing loss or auditory neuropathy, and meet certain age and health requirements.

Will I definitely get the new treatment?

No, you will be randomly placed into one of two groups: one will get the standard cochlear implant surgery, and the other will get the surgery plus the Rincell-1 injection. It's like flipping a coin for which group you're in.

How long will I be part of the study?

You'll be involved for about one year (52 weeks) after your cochlear implant surgery, with regular check-ups and assessments.

What if I change my mind during the study?

You are free to leave the study at any time, for any reason, and it will not affect your usual medical care.

How to find out more

Rachel Haines

enquiries@rinri-therapeutics.com +44 114 222 4330 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.