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 : July 16, 2019
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 :||80 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
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|