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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-19

Study Completion Date

2027-02-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Simultaneous Cochlear Implantation During Translabyrinthine Resection of Vestibular Schwannoma

NCT03958006

Vestibular Schwannoma Cochlear Implantation

COMPLETED NA

Gene Therapy Trial for Otoferlin Gene-mediated Hearing Loss

NCT05821959

Sensorineural Hearing Loss, Bilateral

RECRUITING PHASE1/PHASE2

Long Term Follow-up Study of AAVAnc80-hOTOF Gene Therapy

NCT06696456

Otoferlin Gene-mediated Hearing Loss

ENROLLING_BY_INVITATION

Clinical and Genetic Analysis of Enlarged Vestibular Aqueducts

NCT00023036

Sensorineural Hearing Loss Cytomegalovirus Infection

COMPLETED

Auditory Nerve Test System During Vestibular Schwannoma Resection

NCT04241679

Vestibular Schwannoma Acoustic Neuroma Sensorineural Hearing Loss +5 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hearing Loss, Sensorineural

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AAV viral transduction

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

Peroperative collect of inner ear cells

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)