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出境医 / 临床实验 / Study of Viral Transduction of Human Auditory Sensory Cells for the Development of Gene Therapy (TREATGENE)
Study of Viral Transduction of Human Auditory Sensory Cells for the Development of Gene Therapy (TREATGENE)
Study Description
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
| Study Type : | Observational |
| Estimated Enrollment : | 100 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 |
Arms 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. |
Outcome Measures
Primary Outcome Measures :
- 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
| 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
Contacts
| Contact: Ghizlene Lahlou | 33 1 45688891 | ghizlene.lahlou@pasteur.fr | |
| Contact: Saaid Safieddine | saaid.safieddine@pasteur.fr |
Locations
| 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
| Study Director: | Ghizlene Lahlou | Institut Pasteur |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | June 21, 2019 | ||||||||
| First Posted Date | June 25, 2019 | ||||||||
| Last Update Posted Date | October 22, 2020 | ||||||||
| Actual Study Start Date | February 19, 2019 | ||||||||
| Estimated Primary Completion Date | February 1, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
AAV transduction in inner ear cells [ Time Frame: 10 days ] The transduction will be measured with immunostaining techniques
|
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| Original Primary Outcome Measures |
AAV tranduction in inner ear cells [ Time Frame: 10 days ] The transduction will be measured with immunostaining techniques
|
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| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Study of Viral Transduction of Human Auditory Sensory Cells for the Development of Gene Therapy | ||||||||
| Official Title | Study of Viral Transduction of Human Auditory Sensory Cells for the Development of Gene Therapy | ||||||||
| 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. |
||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Other Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description:
inner ear cells collected during surgery
|
||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients undergoing surgical resection of vestibular schwannoma. | ||||||||
| Condition | Hearing Loss, Sensorineural | ||||||||
| Intervention | 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. |
||||||||
| Study Groups/Cohorts | AAV viral transduction
Collection of inner ear cells during a non-conservative surgical approach (translabyrinthine or transotic).
Intervention: Other: Peroperative collect of inner ear cells
|
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
100 | ||||||||
| Original Estimated Enrollment |
80 | ||||||||
| Estimated Study Completion Date | February 1, 2022 | ||||||||
| Estimated Primary Completion Date | February 1, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
|
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| Listed Location Countries | France | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03996824 | ||||||||
| Other Study ID Numbers | 2017-081 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement |
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| Responsible Party | Institut Pasteur | ||||||||
| Study Sponsor | Institut Pasteur | ||||||||
| Collaborators | Assistance Publique - Hôpitaux de Paris | ||||||||
| Investigators |
|
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| PRS Account | Institut Pasteur | ||||||||
| Verification Date | October 2020 | ||||||||
