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Sensorineural Hearing LossPhase 1/2NCT07032038

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

A Phase 1/2 study testing Otic neural progenitors and cochlear implantation in people with Sensorineural Hearing Loss and Presbyacusis, run by Rinri Therapeutics at 3 sites in United Kingdom.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 74 years
What is being tested?
Otic neural progenitors and cochlear implantation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
3 sitesUnited Kingdom
Study dates
Sep 2027to Aug 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Cohort 1 Only
  • Male or female, 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
  • Cohort 2 Only
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  • Male or female, aged 18-74 years (inclusive) at time of consent
  • Postsynaptic AN characterised by:
  • normal outer hair cell function evidenced by normal OAEs and/or CM response, and aberrant or absent ABRs
  • disparity between relatively preserved pure-tone audiometric thresholds and significantly impaired speech perception abilities, in individuals who do not receive adequate benefit from acoustic HAs
  • Approved for unilateral cochlear implantation as per UK NICE criteria TA566 and NHS England SSC1442
  • All participants (Cohort 1 and Cohort 2)
  • Capable and willing to provide written informed consent
  • History, examination and pre-operative imaging suggesting a healthy middle ear in the ear to be implanted, and a structurally normal and fully patent cochlea with no evidence of a widened vestibular aqueduct
  • Both ears deemed suitable for cochlear implantation
  • Pre-operative imaging suggesting adequate access for surgical approach for the injection of Rincell-1
  • Willingness to be implanted with an Advanced Bionics HiRes Ultra 3D CI and suitable as per device IFU indication
  • A MoCA-HI score of >24
  • English speaker with sufficient comprehension and expressive language to complete questionnaires and speech tests

Who cannot join

  • Cohort 2 Only
  • 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.
  • All participants (Cohort 1 and Cohort 2)
  • History of prelingual hearing loss
  • History of significant hearing loss caused by infection or head trauma
  • History of previous cochlear implantation, in either ear
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  • 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
  • In the ear to be implanted, evidence of anatomical or morphological issues apparent on pre-operative imaging including inner, middle and outer ear malformations (including evidence of a hypoplastic/absent auditory nerve and/or bony/absent IAM) and any known factor that may restrict full insertion of the electrode array or injection of Rincell-1
  • Any known contraindications or concerns about medical fitness for cochlear implantation surgery and the additional surgical steps required for Rincell-1 injection (including BMI ≥35)
  • Any known contraindications or concerns about suitability for any of the trial medicinal products (refer to section 5.2, the IB, NIMP manual (Protocol Appendix 1) and relevant SmPCs)
  • Diagnosis of active, moderate to severe autoimmune disorders or any immune disorder requiring immunosuppression in the past 5 years
  • History of documented severe/significant allergic reaction that required overnight hospital admission, or any history of anaphylactic shock
  • Malignancy under current active treatment or previous malignancy considered at substantial risk for progression or recurrence during trial interval, as determined by the Investigator
  • Previous or current CNS neoplasms or head and neck cancer
  • Previous recipient of a gene therapy, any other type of ATMP, cell or organ transplantation, or recipient of multiple blood transfusions within the past 5 years
  • Unable to be imaged using X-ray and/or MRI (including having any other implanted medical device that is MRI conditional)
  • Currently pregnant or breastfeeding
  • Unwilling to follow contraception requirements of the trial
  • Current or future participation in another interventional research study or any hearing-related research study during the course of trial participation
  • Diagnosis of any syndrome, disorder or disease that is auditory, neurological, neurocognitive, psychological or developmental in nature (including speech and language disorders and dyslexia) which, in the Investigator's judgement, could impact the trial assessments
  • Laboratory confirmed pre-formed specific anti-HLA antibodies to the cell product
  • Any other reason, medical or otherwise, which, in the Investigator's judgment, could interfere with the participant's compliance with the protocol (including undertaking of daily objective testing) or interpretation of the study results, makes participating difficult or burdensome for the participant or compromises participant safety

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Rachel Haines contact

+44 114 222 4330

enquiries@rinri-therapeutics.com

Douglas Hartley contact

douglas.hartley@rinri-therapeutics.com

United Kingdom3 sites

  • University Hospitals Birmingham

    Birmingham

    Peter Monksfield, 01213714518, Peter.Monksfield@uhb.nhs.uk

  • Cambridge University Hospital

    Cambridge

    Matthew Smith, 01223 217589, mes39@cam.ac.uk

  • Guy's and St Thomas' Trust

    London

    Dan Jiang, 02071886245, gstt.hearingimplantsresearch@nhs.net

Other trials in United Kingdom

About this study

Official title: 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

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
Read more

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.

Read the 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.

Being tested
Otic neural progenitors, cochlear implantation
Keywords
neural hearing loss, presbycusis, ANSD, auditory neuropathy, cell therapy, first in human
Medical subject headings
Hearing Loss, Sensorineural, Presbycusis, Auditory neuropathy, Retrocochlear Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Otic neural progenitorsDrug

    Advanced Cell Therapy - tissue engineered product

  • cochlear implantationDevice

    cochlear implant

Study groups in NCT07032038
Study groupRoleWhat they receive
Standard Care Unilateral CI + Rincell-1ExperimentalRoutine unilateral cochlear implantation with simultaneous single dose of Rincell-1
Receives: Drug: Otic neural progenitors; Device: cochlear implantation
Standard Care Unilateral CI onlyActive comparatorRoutine unilateral cochlear implantation only
Receives: Device: cochlear implantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency and severity of AEs

    Frequency and severity of AEs considered related to Rincell-1 alone, the procedure used to administer Rincell-1, and to the CI device and/or the administered concomitant NIMP regime.

    Measured: From baseline (at screening) to 52 weeks post-implantation

Secondary outcomes (2)

  1. Changes in mean ECAP thresholds

    Change from baseline to primary evaluation timepoint in mean ECAP threshold, measured at each electrode for each participant

    Measured: From post-implantation baseline to 40 weeks post-implantation

  2. Feasibility of administration of Rincell-1

    Evaluated in terms of:

    • On-time delivery to theatre of the DP
    • Successful in-theatre DP preparation
    • Injection of the full DP into the target anatomical structure
    • DP sterility and viability

    Measured: At time of administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2025
  2. Study startSep 2027 (estimated)
  3. Primary completionMay 2029 (estimated)
  4. Study completionAug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07032038
Sponsor's protocol ID
R1-25
Status last verified
Sep 2026
First submitted
13 Jun 2025
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Otic neural progenitors and cochlear implantation in people with Sensorineural Hearing Loss and Presbyacusis, run by Rinri Therapeutics at 3 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rachel Haines (+44 114 222 4330, enquiries@rinri-therapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency and severity of AEs (time frame: From baseline (at screening) to 52 weeks post-implantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07032038.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.

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