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

NCT07032038 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: R1-25
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief 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

Presbyacusis; Auditory Neuropathy; Sensorineural Hearing Loss

Keywords

neural hearing loss; presbycusis; ANSD; auditory neuropathy; cell therapy; first in human

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (2)

• Changes in mean ECAP thresholds

  From post-implantation baseline to 40 weeks post-implantation

• Feasibility of administration of Rincell-1

  At time of administration

Study Arms (2)

Standard Care Unilateral CI + Rincell-1

EXPERIMENTAL

Routine unilateral cochlear implantation with simultaneous single dose of Rincell-1

Drug: Otic neural progenitors; Device: cochlear implantation

Standard Care Unilateral CI only

ACTIVE COMPARATOR

Routine unilateral cochlear implantation only

Device: cochlear implantation

Interventions

Otic neural progenitors DRUG

Advanced Cell Therapy - tissue engineered product

Standard Care Unilateral CI + Rincell-1

cochlear implantation DEVICE

cochlear implant

Standard Care Unilateral CI + Rincell-1; Standard Care Unilateral CI only

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cohort 1 Only
• 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
• 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

You may not qualify if:

• 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
• 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 treatment

Sponsors & Collaborators

• Rinri Therapeutics: lead
• King's College London: collaborator

Study Sites (3)

University Hospitals Birmingham

Birmingham, United Kingdom

Location

Cambridge University Hospital

Cambridge, United Kingdom

Location

Guy's and St Thomas' Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural; Presbycusis; Auditory neuropathy; Retrocochlear Diseases

Interventions

Cochlear Implantation

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Otologic Surgical Procedures; Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation

Study Officials

• Douglas Hartley

  Rinri Therapeutics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Haines

CONTACT

+44 114 222 4330; enquiries@rinri-therapeutics.com

Douglas Hartley

CONTACT

douglas.hartley@rinri-therapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Trial statistician, primary and secondary outcomes assessors
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 22, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)