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NCT Number: NCT06407102

Collection of Primary Human

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AUSSEDAT

Tours, France

Location status: Recruiting

Location contact

CHARLES AUSSEDAT

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Collection of nasal cells during programme surgery

Other

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.

Primary outcomes

  1. Percentage of viability of nasal epithelial cells from the operating room to laboratory

    Time frame: 6 hours

    Collect nasal epithelial cells that can be grown in vitro in an air-liquid interface

Secondary outcomes

  1. Percentage of efficacy of the procedure

    Time frame: 3 years

    Percentage of samples that can actually be cultivated following transfer to the laboratory.

Study contacts

Contact information is provided by the study sponsor or research team.

Adeline Mousset

CONTACT

[email protected]

0218370645

Charles Aussedat, MD

CONTACT

[email protected]

0247474747

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study title

Collection of Primary Human Nasal Epithelial Cells

Acronym: BIONOSE

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
May 9, 2024
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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