Collection of Primary Human

Nasal Disease Clinical Trial

— BIONOSE  

Official title:

Collection of Primary Human Nasal Epithelial Cells

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06407102
• Other study ID #: DR230317
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 2, 2028
• Est. primary completion date: May 2, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Nasal Disease
• Nose Diseases

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of viability of nasal epithelial cells from the operating room to laboratory	Collect nasal epithelial cells that can be grown in vitro in an air-liquid interface	6 hours
Secondary	Percentage of efficacy of the procedure	Percentage of samples that can actually be cultivated following transfer to the laboratory.	3 years