Gene therapy approach for treating hearing loss using human inner ear cells
Official title: Study of Viral Transduction of Human Auditory Sensory Cells for the Development of Gene Therapy
Run by Institut Pasteur · NCT03996824 · Data updated 2026-11-12
This study is testing a new gene therapy using a virus to see if it can help treat hearing loss by working with inner ear cells taken from patients during certain surgeries.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Institut Pasteur Industry-sponsored |
| Locations | 2 sites (Le Kremlin-Bicêtre, Île-de-France Region and 1 other locations) |
| Status | Recruiting |
| Started | February 19, 2019 |
| Main results expected | February 18, 2027 |
| Study ends | February 18, 2027 |
| Registry record updated | September 19, 2024 |
| Trial ID | NCT03996824 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who require non-conservative surgery for vestibular schwannoma.
✕Probably not a fit
Patients with intravestibular or intra-cochlear tumor extension or those with medical contraindications may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates the use of adeno-associated virus (AAV) for gene therapy targeting hearing loss and vestibular disorders. It focuses on the viral transduction of human auditory sensory cells collected during surgeries for vestibular schwannoma. The study aims to enhance understanding of how AAV can be utilized in the inner ear, potentially paving the way for future therapeutic applications. Participants will be patients undergoing specific surgical procedures, allowing for the collection of inner ear cells for analysis.
Why it matters
Potential benefit: If successful, this research could lead to innovative gene therapies that restore hearing in individuals with sensorineural hearing loss.
How similar studies have gone: While gene therapy for hearing loss is a promising area, this specific approach using AAV in human inner ear cells is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient ≥ 18 years old * Operative indication for a non-conservative resection of vestibular schwannoma, decided by the surgeon in accordance with the patient * Informed consent obtained * Patients with a french social protection (AME excluded) Exclusion Criteria: * Intravestibular or intra-cochlear extension of the tumor * Pregnant woman * Patient with administrative control * Medical contra-indication
Where it's running
-
Hôpital de Bicêtre
Le Kremlin-Bicêtre, Île-de-France Region, France Recruiting -
Hôpital Pitié-Salpétrière
Paris, Île-de-France Region, France Recruiting
Study contacts
- Study coordinator: Ghizlene Lahlou
- Email: ghizlene.lahlou@pasteur.fr
- Phone: 33 1 45688891
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.