Recruiting NCT03996824
Study of Viral Transduction of Human Auditory Sensory Cells for the Development of Gene Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Peroperative collect of inner ear cells.
- Who it may be relevant to
- Registry conditions: Hearing Loss, Sensorineural. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Gene therapy is a promising strategy to treat hearing loss and vestibular disorders, and Associated adenovirus (AAV) is shown as a good viral vector for inner ear therapy in animal models. This study aims to study in vitro viral transduction of AAV in human inner ear cells, collected during non-conservative surgeries for vestibular schwannoma.
Interventions
- Other Peroperative collect of inner ear cells
After obtaining an informed consent during the preoperative medical visit, and if a non-conservative approach (translabyrinthine or transotic) is decided, the collect of inner ear cells will be performed during surgical approach. The sample will be collect in a sterile tube, and carried to the laboratory were it will be placed bon cell culture.
Primary outcome measures
- AAV transduction in inner ear cells [Time frame: 10 days]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
France · 2 centers
- Hôpital de Bicêtre — Le Kremlin-Bicêtre
- Hôpital Pitié-Salpétrière — Paris
Identifiers
NCT: NCT03996824 · 2017-081