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

Pasteur Institute

Status: Enrolling

Conditions: Hearing Loss, Sensorineural

Treatments: Other: Peroperative collect of inner ear cells

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03996824

2017-081

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

AAV viral transduction

Description:

Collection of inner ear cells during a non-conservative surgical approach (translabyrinthine or transotic).

Treatment:

Other: Peroperative collect of inner ear cells