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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.


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.

Study Design


Related Conditions & MeSH terms


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
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