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

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.

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Key information

Conditions

Hearing Loss, Sensorineural Ear Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital de Bicêtre, Le Kremlin-Bicêtre, Île-de-France Region, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peroperative collect of inner ear cells

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.

Primary outcomes

AAV transduction in inner ear cells

Time frame: 10 days

The transduction will be measured with immunostaining techniques

Study contacts

Contact information is provided by the study sponsor or research team.

Ghizlene Lahlou

CONTACT

[email protected]

33 1 45688891

Saaid Safieddine

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Institut Pasteur

Industry

Collaborators

Assistance Publique - Hôpitaux de Paris

Registry information

Acronym: TREATGENE

Important dates

Study start: 2019
Primary completion: 2027
Study completion: 2027
First posted: Jun 25, 2019
Registry last updated: Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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