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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03996824
Acronym
TREATGENE
Enrollment
100
Registered
2019-06-25
Start date
2019-02-19
Completion date
2027-02-18
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss, Sensorineural

Brief 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.

Interventions

OTHERPeroperative 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.

Sponsors

Assistance Publique - Hôpitaux de Paris
CollaboratorOTHER
Institut Pasteur
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
AAV transduction in inner ear cells10 daysThe transduction will be measured with immunostaining techniques

Countries

France

Contacts

Primary ContactGhizlene Lahlou
ghizlene.lahlou@pasteur.fr33 1 45688891
Backup ContactSaaid Safieddine
saaid.safieddine@pasteur.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026