[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"presbyacusis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:presbyacusis":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100595406","phase-1-first-in-human-randomised-trial-of-rincell-1-in-adults-with-a-cochlear-implant-100595406",false,"NCT07032038","First In Human Randomised Trial of Rincell-1 in Adults With a Cochlear Implant","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","Inclusion Criteria:\n\nCohort 1 Only\n\n1. Aged 60-74 years (inclusive) at time of consent\n2. Hearing Loss due to bilateral progressive presbycusis\n3. Approved for unilateral cochlear implantation as per UK NICE criteria (TA566)\n4. 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\n\n   Cohort 2 Only\n5. Aged 18-74 years (inclusive) at time of consent\n6. Postsynaptic AN characterised by:\n\n   * normal outer hair cell function evidenced by normal OAEs and\u002For CM response, and aberrant or absent ABRs\n   * 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\n7. Approved for unilateral cochlear implantation as per UK NICE criteria TA566 and NHS England SSC1442\n\n   All participants (Cohort 1 and Cohort 2)\n8. Capable and willing to provide written informed consent\n9. 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\n10. Both ears deemed suitable for cochlear implantation\n11. Pre-operative imaging suggesting adequate access for surgical approach for the injection of Rincell-1\n12. Willingness to be implanted with an Advanced Bionics HiRes Ultra 3D CI and suitable as per device IFU indication\n13. A MoCA-HI score of \\>24\n14. English speaker with sufficient comprehension and expressive language to complete questionnaires and speech tests\n\nExclusion Criteria:\n\nCohort 2 Only\n\n1. 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.\n\n   All participants (Cohort 1 and Cohort 2)\n2. History of prelingual hearing loss\n3. History of significant hearing loss caused by infection or head trauma\n4. History of previous cochlear implantation, in either ear\n5. Documented hearing loss secondary to ototoxic medications\n6. Suspected or confirmed hearing loss that is wholly or partly unexplained by anatomic or physiologic abnormalities (non-organic hearing loss)\n7. 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\n8. History of diagnosed sudden SNHL, Ménière's disease, otosclerosis, cholesteatoma, acoustic neuroma, meningitis or confirmed\u002Fsuspected autoimmune inner ear disease\n9. 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\u002Fabsent auditory nerve and\u002For bony\u002Fabsent IAM) and any known factor that may restrict full insertion of the electrode array or injection of Rincell-1\n10. 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)\n11. 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)\n12. Diagnosis of active, moderate to severe autoimmune disorders or any immune disorder requiring immunosuppression in the past 5 years\n13. History of documented severe\u002Fsignificant allergic reaction that required treatment\n14. Malignancy under current active treatment or previous malignancy considered at substantial risk for progression or recurrence during trial interval, as determined by the Investigator\n15. Previous or current CNS neoplasms or head and neck cancer\n16. 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\n17. Unable to be imaged using X-ray and\u002For MRI (including having any other implanted medical device that is MRI conditional)\n18. Currently pregnant or breastfeeding\n19. Unwilling to follow contraception requirements of the trial\n20. Current or future participation in another interventional research study or any hearing-related research study during the course of trial participation\n21. 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\n22. Laboratory confirmed pre-formed specific anti-HLA antibodies to the cell product\n23. 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","ALL","18 Years","74 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","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:\n\n* 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\n* To evaluate how well Rincell-1 works by measuring changes in the function of auditory neurons.\n* To understand if Rincell-1 can be easily and successfully given at the same time as cochlear implant surgery\n\nParticipants 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.\n\nParticipants 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.",[28,29,30],"Sensorineural Hearing Loss","Presbyacusis","Auditory Neuropathy",[32,33,34,35,36,37],"neural hearing loss","presbycusis","ANSD","auditory neuropathy","cell therapy","first in human","NOT_YET_RECRUITING","2026-05-11",{"date":41,"type":42},"2026-05-12","ACTUAL",{"date":44,"type":21},"2026-05",{"date":46,"type":21},"2028-02",{"name":48,"class":49},"Rinri Therapeutics","INDUSTRY",3,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":65,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":5},"100463306","development-of-a-battery-of-audiological-tests-for-the-precision-diagnosis-of-age-related-hearing-loss-100463306","NCT05312983","Development of a Battery of Audiological Tests for the Precision Diagnosis of Age-related Hearing Loss","AUDIOGENAGE","Inclusion Criteria:\n\nFor all participants:\n\n* Be over the age of 18,\n* Be affiliated to a social security system,\n* Have a good command of the French language (oral and written).\n\nFor the group of participants with anticipated presbycusis:\n\n* Over the age of 40, having a hearing aid recipient or coming for a first hearing aid recipient\n* Between 18 and 40, having a hearing aid recipient, coming for a first hearing aid recipient or declare a progressive genetic birth defect\n\nFor healthy volunteers:\n\n\\- Have no known hearing loss.\n\nExclusion Criteria:\n\n* Report having been chronically exposed to loud sounds.\n* Have a history of ototoxic substances,\n* To have sequelae of ear infections and\u002For a history of ENT disease that permanently affects hearing or balance,\n* Have an ethnic origin for which the Pasteur Institute does not have information on the frequency of variants of the genes studied.\n* Have type II diabetes,\n* Have a neurological or psychiatric condition that interferes with comprehension or ability to move,\n* Be under guardianship,\n* Be deprived of liberty by judicial or administrative decision, or be subject to legal protection,\n* Not being subject to a social security system,\n* Taking narcotic substances, alcohol or medication that diminishes cognitive abilities.",true,{"count":60,"type":21},700,[62],"NA","Age-related hearing loss, or presbycusis, is caused by many genetic and environmental factors. Its prevalence poses a public health challenge of early identification and effective hearing aid treatment. However, the lack of screening and of a validated audiological test battery to diagnose an individual's needs and to guide hearing aid adjustments is a major obstacle.\n\nFurthermore, monogenic forms of hearing loss affect only one functional module of hearing. The audiological test(s) dependent on the function of this module are affected, in a progressive manner, but not the others. A previous study showed that in early onset presbycusis patients, a quarter of the subjects tested were affected by monogenic presbycusis.\n\nThe collection of audiological and vestibular tests, carried out on proven monogenic presbycusis patients and compared to that of normal hearing patients, would constitute a battery of tests allowing a precision diagnosis, then developed to all forms of presbycusis in order to study if the identification of abnormal functional modules can usefully guide the diagnosis and the early fitting.",[29],[66,67,68,69],"presbyacusis","aging","audiology","genetic","RECRUITING","2025-02-28",{"date":73,"type":42},"2025-03-03",{"date":75,"type":42},"2022-07-28",{"date":77,"type":21},"2030-12-31",{"name":79,"class":49},"Institut Pasteur"]