Gene therapy approach for treating hearing loss using human inner ear cells
Study of Viral Transduction of Human Auditory Sensory Cells for the Development of Gene Therapy
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Pasteur Industry-sponsored |
| Locations | 2 sites (Le Kremlin-Bicêtre, Île-de-France Region and 1 other locations) |
| Trial ID | NCT03996824 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who require non-conservative surgery for vestibular schwannoma.
Not a fit: Patients with intravestibular or intra-cochlear tumor extension or those with medical contraindications may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Le Kremlin-Bicêtre, Île-de-France Region and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.