First In Human Randomised Trial of Rincell-1 in Adults With a Cochlear Implant
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-74
SponsorRinri Therapeutics
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
History of prelingual hearing loss
History of significant hearing loss caused by infection or head trauma
History of previous cochlear implantation, in either ear
Trial design
Design model
Parallel
Treatments tested in this trial
Otic neural progenitors
DrugAdvanced Cell Therapy - tissue engineered product
cochlear implantation
Devicecochlear implant
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Standard Care Unilateral CI + Rincell-1Experimental treatment 2 interventions
Group B: Standard Care Unilateral CI onlyActive comparator 1 intervention
Trial outcomes
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.
Time frame
From baseline (at screening) to 52 weeks post-implantationSecondary outcomes
1
Changes in mean ECAP thresholds
Change from baseline to primary evaluation timepoint in mean ECAP threshold, measured at each electrode for each participant
Time frame
From post-implantation baseline to 40 weeks post-implantation2
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
Time frame
At time of administrationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Rinri Therapeutics
Lead sponsor
King's College London
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: