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

StatusNot Yet Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 5 months later across 2 updates Nov 2027 → May 2029
See other at-risk trials from Rinri Therapeutics

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jul 2028 to May 2029 Show 7 more changesShow less
    • Start date: Nov 2026 to Sep 2027
    • Study completion pushed from Oct 2028 to Aug 2029
    • Eligibility criteria expanded, about 53 words
    • Secondary endpoints: details revised at 1 of 2 entries
    • Site details revised at 1 of 3 sites
    • Collaborators: details revised at 1 of 1 entry
    • Study description expanded, about 2 words
  2. Primary completion pushed from Nov 2027 to Jul 2028
    • Start date: May 2026 to Nov 2026
    • Study completion pushed from Feb 2028 to Oct 2028
    • Site contacts updated at 1 of 3 sites
    v7
  3. Site contacts updated at 1 of 3 sitesv6
  4. Primary completion date: Apr 2027 to Nov 2027
    • Start date: Oct 2025 to May 2026
    • Study completion date: Jul 2027 to Feb 2028
    • Eligibility criteria expanded, about 5 words
    v5
  5. 2 versions Re-verified since Jul 3, 2025, no change to tracked fieldsv3-v4
  6. Primary endpoint revised
    • Eligibility criteria revised
    • Secondary endpoints revised (2)
    • Study description revised
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07032038
Lead Sponsor Rinri Therapeutics
Collaborators: King's College London
Conditions
(from sponsor)		 Sensorineural Hearing Loss, Presbyacusis, Auditory Neuropathy
Related terms Auditory neuropathy, Hearing Loss, Sensorineural, Presbycusis, Retrocochlear Diseases
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov