Study of Viral Transduction of Human Auditory Sensory Cells for the Development of Gene Therapy

Hearing Loss, Sensorineural Clinical Trial

— TREATGENE  

Official title:

Study of Viral Transduction of Human Auditory Sensory Cells for the Development of Gene Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03996824
• Other study ID #: 2017-081
• Status: Recruiting
• Start date: February 19, 2019
• Est. completion date: February 18, 2027

Study information

• Verified date: July 2023
• Source: Institut Pasteur
• Contact: Ghizlene Lahlou
• Phone: 33 1 45688891
• Email: ghizlene.lahlou[@]pasteur.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 18, 2027
• Est. primary completion date: February 18, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Sensorineural

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital de Bicêtre	Le Kremlin-Bicêtre	Ile De France
France	Hôpital Pitié-Salpétrière	Paris	Ile De France

Sponsors (2)

Lead Sponsor	Collaborator
Institut Pasteur	Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AAV transduction in inner ear cells	The transduction will be measured with immunostaining techniques	10 days