Collection of Primary Human

Официальное название

Collection of Primary Human Nasal Epithelial Cells

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Collection of nasal cells during programme surgery
  During programmed surgery (meatotomy, septoplasty or turbinoplasty for example, or other programmed surgeries), the surgeon will take an atraumatic sample from the nasal cavity using a dedicated device (brush) from the healthy nasal mucosa.

Первичные конечные точки

• Percentage of viability of nasal epithelial cells from the operating room to laboratory [Срок оценки: 6 hours]

Вторичные конечные точки (1)

• Percentage of efficacy of the procedure [Срок оценки: 3 years]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Франция · 1 центр

• AUSSEDAT — Tours

Идентификаторы

NCT: NCT06407102 · DR230317

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗