Rincell-1 — Otic Neural Progenitors Combined with Cochlear Implant, First-in-Human Phase 1/2
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| Trial ID | NCT07032038 ↗ |
|---|---|
| Sponsor | Rinri Therapeutics · UK |
| Cell Source | otic-neural-progenitors · allogeneic |
| Indication | sensorineural-hearing-loss |
| Phase | PHASE 1 2 |
| Status | NOT-YET-RECRUITING |
| Delivery Route | cell injection during cochlear implant surgery |
| Enrollment | 20 |
| Publication | — |
Trial Design
The Rincell-1 study is a first-in-human randomised clinical trial evaluating an otic neural progenitor cell therapy in adults undergoing cochlear implantation. Participants in the experimental arm receive Rincell-1 alongside the cochlear implant procedure; those in the control arm receive the standard cochlear implant alone. The primary endpoint is the frequency and severity of adverse events related to Rincell-1, the delivery procedure, the cochlear implant device, and concomitant medications. Secondary endpoints include changes in electrically evoked compound action potential (ECAP) threshold and the feasibility of cell delivery.
Clinical Significance
This study illustrates that regenerative medicine is not exclusively developed as standalone therapies — it can be integrated with established surgical procedures and medical devices. Cochlear implantation is an already well-established intervention, but combining it with otic neural progenitor cells opens the possibility of enhancing auditory nerve responsiveness.
Reasons Rincell-1 is drawing attention:
- First-in-human — the first cell therapy trial of its kind in this indication
- Medical device integration — cell therapy combined with cochlear implantation
- Otic neural progenitors — an emerging area within sensory organ regenerative medicine
- Functional physiological endpoint — ECAP threshold as a measure of auditory nerve response
Limitations and Discussion
As an early-phase trial, establishing safety and delivery feasibility is the primary objective. Whether improvements in auditory nerve response translate into real gains in speech perception, listening ability, and quality of life will require further study. The stable delivery and survival of cells at the target site, and the absence of long-term adverse events, also need to be confirmed.