Study of Viral Transduction of Human Auditory Sensory Cells for the Development of Gene Therapy (TREATGENE)
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|ClinicalTrials.gov Identifier: NCT03996824|
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : October 22, 2020
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.
|Condition or disease||Intervention/treatment|
|Hearing Loss, Sensorineural||Other: Peroperative collect of inner ear cells|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Study of Viral Transduction of Human Auditory Sensory Cells for the Development of Gene Therapy|
|Actual Study Start Date :||February 19, 2019|
|Estimated Primary Completion Date :||February 1, 2022|
|Estimated Study Completion Date :||February 1, 2022|
AAV viral transduction
Collection of inner ear cells during a non-conservative surgical approach (translabyrinthine or transotic).
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.
- AAV transduction in inner ear cells [ Time Frame: 10 days ]The transduction will be measured with immunostaining techniques
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996824
|Contact: Ghizlene Lahlou||33 1 firstname.lastname@example.org|
|Contact: Saaid Safieddineemail@example.com|
|Hôpital de Bicêtre||Recruiting|
|Le Kremlin-Bicêtre, Ile De France, France, 94270|
|Contact: Jérôme Nevoux, MD firstname.lastname@example.org|
|Principal Investigator: Jérôme Nevoux, MD|
|Paris, Ile De France, France, 75015|
|Contact: Yann Nguyen, MD email@example.com|
|Principal Investigator: Yann Nguyen, MD|
|Study Director:||Ghizlene Lahlou||Institut Pasteur|