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

July 17, 2023 updated by: Institut Pasteur

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Ile De France
      • Le Kremlin-Bicêtre, Ile De France, France, 94270
        • Recruiting
        • Hopital de Bicetre
        • Contact:
        • Principal Investigator:
          • Jérôme Nevoux, MD
      • Paris, Ile De France, France, 75015
        • Recruiting
        • Hôpital Pitié-Salpêtrière
        • Contact:
        • Principal Investigator:
          • Yann Nguyen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing surgical resection of vestibular schwannoma.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AAV viral transduction
Collection of inner ear cells during a non-conservative surgical approach (translabyrinthine or transotic).
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AAV transduction in inner ear cells
Time Frame: 10 days
The transduction will be measured with immunostaining techniques
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Pasteur

Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

  • Study Director: Ghizlene Lahlou, Institut Pasteur

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2019

Primary Completion (Estimated)

February 18, 2027

Study Completion (Estimated)

February 18, 2027

Study Registration Dates

First Submitted

June 21, 2019

First Submitted That Met QC Criteria

June 21, 2019

First Posted (Actual)

June 25, 2019

Study Record Updates

Last Update Posted (Actual)

July 18, 2023

Last Update Submitted That Met QC Criteria

July 17, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-081

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hearing Loss, Sensorineural

Clinical Trials on Peroperative collect of inner ear cells

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe