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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03996824
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : July 16, 2019
Sponsor:
Collaborator:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Institut Pasteur

Study Description
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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.


Condition or disease Intervention/treatment
Hearing Loss, Sensorineural Other: Peroperative collect of inner ear cells

Study Design
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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Study of Viral Transduction of Human Auditory Sensory Cells for the Development of Gene Therapy
Actual Study Start Date : February 19, 2019
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : February 1, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. AAV transduction in inner ear cells [ Time Frame: 10 days ]
    The transduction will be measured with immunostaining techniques


Biospecimen Retention:   Samples With DNA
inner ear cells collected during surgery

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing surgical resection of vestibular schwannoma.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996824


Contacts
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Contact: Ghizlene Lahlou 33 1 45688891 ghizlene.lahlou@pasteur.fr
Contact: Saaid Safieddine saaid.safieddine@pasteur.fr

Locations
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France
Hôpital de Bicêtre Recruiting
Le Kremlin-Bicêtre, Ile De France, France, 94270
Contact: Jérôme Nevoux, MD       jerome.nevoux@aphp.fr   
Principal Investigator: Jérôme Nevoux, MD         
Hôpital Pitié-Salpétrière Recruiting
Paris, Ile De France, France, 75015
Contact: Yann Nguyen, MD       yann.nguyen@aphp.fr   
Principal Investigator: Yann Nguyen, MD         
Sponsors and Collaborators
Institut Pasteur
Assistance Publique - Hôpitaux de Paris
Investigators
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Study Director: Ghizlene Lahlou Institut Pasteur
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Institut Pasteur
ClinicalTrials.gov Identifier: NCT03996824    
Other Study ID Numbers: 2017-081
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hearing Loss
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms