Hearing Loss, SensorineuralTREATGENENCT03996824
Study of Viral Transduction of Human Auditory Sensory Cells for the Development of Gene Therapy
An observational study of Hearing Loss, Sensorineural, run by Institut Pasteur at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Sensorineural
- What is being tested?
- Peroperative collect of inner ear cells
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- 19 Feb 2019to 18 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing surgical resection of vestibular schwannoma.
Who may be able to join
- 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)
Who cannot join
- Intravestibular or intra-cochlear extension of the tumor
- Pregnant woman
- Patient with administrative control
- Medical contra-indication
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Saaid Safieddine contact
France2 sites, 2 recruiting
- Recruiting
Hôpital de Bicêtre
Le Kremlin-Bicêtre, Île-de-France Region, 94270
Jérôme Nevoux, MD, jerome.nevoux@aphp.fr
Jérôme Nevoux, MD
- Recruiting
Hôpital Pitié-Salpétrière
Paris, Île-de-France Region, 75015
Yann Nguyen, MD, yann.nguyen@aphp.fr
Yann Nguyen, MD
About this study
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.
- Conditions
- Hearing Loss, Sensorineural
- Being tested
- Peroperative collect of inner ear cells
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peroperative collect of inner ear cellsOther
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 group | Role | What they receive |
|---|---|---|
| AAV viral transduction | Collection of inner ear cells during a non-conservative surgical approach (translabyrinthine or transotic). Receives: Other: Peroperative collect of inner ear cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
AAV transduction in inner ear cells
The transduction will be measured with immunostaining techniques
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start19 Feb 2019
- Primary completion18 Feb 2027 (estimated)
- Study completion18 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- More trials run by Institut PasteurThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Responsible party
- Sponsor
- Investigators
- Ghizlene Lahlou, Study director, Institut Pasteur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03996824
- Sponsor's protocol ID
- 2017-081
- Acronym
- TREATGENE
- Status last verified
- Sep 2024
- First submitted
- 21 Jun 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Viral Transduction of Human Auditory Sensory Cells for the Development of Gene Therapy
- ClinicalTrials.gov ID
- NCT03996824
- Acronym / sponsor ID
- TREATGENE / 2017-081
- Conditions
- Hearing Loss, Sensorineural
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 18 Feb 2027 (estimated)
- Study completion
- 18 Feb 2027 (estimated)
- First posted
- 25 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AAV viral transduction | – | Other: Peroperative collect of inner ear cellsCollection of inner ear cells during a non-conservative surgical approach (translabyrinthine or transotic). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing surgical resection of vestibular schwannoma.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- Intravestibular or intra-cochlear extension of the tumor
- Pregnant woman
- Patient with administrative control
- Medical contra-indication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peroperative collect of inner ear cellsAfter 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. | Other | AAV viral transduction |
Primary outcome
AAV transduction in inner ear cells
Time frame: 10 days
The transduction will be measured with immunostaining techniques
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Saaid Safieddine contact
Ghizlene Lahlou study director
Institut Pasteur
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, Sensorineural, run by Institut Pasteur at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ghizlene Lahlou (33 1 45688891, ghizlene.lahlou@pasteur.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AAV transduction in inner ear cells (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.