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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitut Pasteur

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Intravestibular or intra-cochlear extension of the tumor

Pregnant woman

Patient with administrative control

Medical contra-indication

Trial population

Patients undergoing surgical resection of vestibular schwannoma.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Peroperative collect of inner ear cells

    Other intervention

    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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: AAV viral transduction1 intervention

Trial outcomes

Primary outcomes

1

AAV transduction in inner ear cells

The transduction will be measured with immunostaining techniques

Time frame
10 days

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut Pasteur

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Collaborator