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临床试验/NCT03996824
NCT03996824招募中不适用

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

Institut Pasteur2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年2月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
AAV transduction in inner ear cells

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • Intravestibular or intra-cochlear extension of the tumor
  • Pregnant woman
  • Patient with administrative control
  • Medical contra-indication

结局指标

主要结局

AAV transduction in inner ear cells

时间窗: 10 days

The transduction will be measured with immunostaining techniques

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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