Collection of Primary Human Nasal Epithelial Cells
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Percentage of viability of nasal epithelial cells from the operating room to laboratory
研究概览
简要总结
Treatment and prevention of respiratory infections are of great interest in many medical areas. Create a physical device covered by primary human nasal cells could be very usefull in order to analyse delivery and efficiency of drugs. In this context the aim of this project is to create a collection of primary cells from the human nasal epithelium.
This collection will be realised during programmed surgery, thanks to a specific device dedicated to collect nasal cells. Then the cells will be sent to the lab in order to grow at the air-liquid interface, which is an excellent 'ex vivo' model for their study.
详细描述
The treatment and prevention of respiratory infections caused by emerging viruses or antibiotic-resistant bacteria are major societal and medical challenges. Inhalation allows drugs to be administered in the form of a spray or aerosol, directly into the respiratory tract (nose or lung). This is a validated approach for the non-invasive delivery of drugs to prevent and treat respiratory diseases, particularly infectious ones. Primary human nasal cell cultures grown at the air-liquid interface are an excellent 'ex vivo' model for their study in a physiological and pathophysiological context, and for testing new therapies, including aerosols. In addition, this culture model also offers an alternative to animal experimentation.
The aim of this project is therefore to create a collection of primary cells from the human nasal epithelium.
The main objective is to obtain a minimum of 60 samples of nasal epithelial cells from patients that can be cultured in air-liquid interface. The secondary objectives are to be able to study these nasal cells under physiological and pathophysiological conditions. The cells will first be amplified to constitute a cell biobank. They will then be studied under physiological conditions (anatomical and functional characterisation). Finally, they can be used to establish different models of infection or inflammation, in order to test future aerosol drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients (age > 18 years) whose native language is French, or who understands French.
- •Affiliation with a French social security system (CMU accepted).
- •Informed consent, written and signed by the participant.
- •Planned rhinological surgery (meatotomy, septoplasty or turbinoplasty for example, but other surgeries as well)
排除标准
- •Patients under court protection, guardianship or curatorship.
- •Pregnant or breast-feeding women (positive pregnancy test for women of childbearing age).
- •Patients presenting a major alteration of the mucosa or a malignant rhinosinus pathology.
研究组 & 干预措施
Patient with programmed surgery
Patient programmed with surgery of meatotomy, septoplasty or turbinoplasty, or other programmed surgeries
干预措施: Collection of nasal cells during programme surgery (Other)
结局指标
主要结局
Percentage of viability of nasal epithelial cells from the operating room to laboratory
时间窗: 6 hours
Collect nasal epithelial cells that can be grown in vitro in an air-liquid interface
次要结局
- Percentage of efficacy of the procedure(3 years)