Collection of Primary Human (BIONOSE)

Collection of Primary Human Nasal Epithelial Cells

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Nasal Disease
• Intervention / Treatment: Other: Collection of nasal cells during programme surgery

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Charles Aussedat, MD; Phone Number: 0247474747; Email: c.aussedat@chu-tours.fr
• Study Contact Backup: Name: Adeline MOUSSET; Phone Number: 0218370645; Email: a.fourmy@chu-tours.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patient with programmed surgery; Patient programmed with surgery of meatotomy, septoplasty or turbinoplasty, or other programmed surgeries	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of efficacy of the procedure	Percentage of samples that can actually be cultivated following transfer to the laboratory.	3 years

Collaborators and Investigators

• Sponsor: University Hospital, Tours

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2024
• Primary Completion (Estimated): May 2, 2027
• Study Completion (Estimated): May 2, 2028

Study Registration Dates

• First Submitted: May 6, 2024
• First Submitted That Met QC Criteria: May 6, 2024
• First Posted (Actual): May 9, 2024

Study Record Updates

• Last Update Posted (Actual): June 3, 2024
• Last Update Submitted That Met QC Criteria: May 31, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: nasal cells; Respiratory epithelium
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Nose Diseases
• Other Study ID Numbers: DR230317

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No