Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06407102 |
Other study ID # |
DR230317 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
June 30, 2024 |
Est. completion date |
May 2, 2028 |
Study information
Verified date |
May 2024 |
Source |
University Hospital, Tours |
Contact |
Charles Aussedat, MD |
Phone |
0247474747 |
Email |
c.aussedat[@]chu-tours.fr |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.