Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06407102
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-06
Brief Title:
Collection of Primary Human
Sponsor:
University Hospital Tours
Organization:
University Hospital Tours
Study Overview
Official Title:
Collection of Primary Human Nasal Epithelial Cells
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIONOSE
Brief 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
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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None