Study of Viral Transduction of Human Auditory Sensory Cells for the Development of Gene Therapy
TREATGENE
1 other identifier
observational
100
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2019
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 19, 2019
CompletedFirst Submitted
Initial submission to the registry
June 21, 2019
CompletedFirst Posted
Study publicly available on registry
June 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 18, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 18, 2027
September 19, 2024
September 1, 2024
8 years
June 21, 2019
September 10, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
AAV transduction in inner ear cells
The transduction will be measured with immunostaining techniques
10 days
Study Arms (1)
AAV viral transduction
Collection of inner ear cells during a non-conservative surgical approach (translabyrinthine or transotic).
Interventions
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.
Eligibility Criteria
Patients undergoing surgical resection of vestibular schwannoma.
You may qualify if:
- 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)
You may not qualify if:
- Intravestibular or intra-cochlear extension of the tumor
- Pregnant woman
- Patient with administrative control
- Medical contra-indication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut Pasteurlead
- Assistance Publique - Hôpitaux de Pariscollaborator
Study Sites (2)
Hôpital de Bicêtre
Le Kremlin-Bicêtre, Île-de-France Region, 94270, France
Hôpital Pitié-Salpétrière
Paris, Île-de-France Region, 75015, France
Biospecimen
inner ear cells collected during surgery
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ghizlene Lahlou
Institut Pasteur
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2019
First Posted
June 25, 2019
Study Start
February 19, 2019
Primary Completion (Estimated)
February 18, 2027
Study Completion (Estimated)
February 18, 2027
Last Updated
September 19, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share