Trials / Completed
CompletedNCT03181204
Modeling Bronchial Epithelium Modifications Associated With COPD Using iPS
Modeling Bronchial Epithelia Modifications Associated With Chronic Obstructive Pulmonary Disease (COPD) Using Induced Pluripotent Stemcells (iPS)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 11 (actual)
- Sponsor
- University Hospital, Montpellier · Academic / Other
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to to verify the feasibility of obtaining and comparing two epithelia in two populations based on the following experiments: * Differentiation of an Induced Pluripotent Stem cell (iPS) clone derived from cutaneous biopsy in a population of heavy smokers (plus patients with chronic obstructive pulmonary disease) in order to obtain differentiated bronchial epithelia in vitro. * For each of these same patients, generation of bronchial epithelium in vitro from bronchial biopsy using human bronchial epithelial cells (HBECs) in air-liquid interface (ALI) cultures.
Detailed description
Secondary objectives: * Confrontation of the two models of in vitro generation of bronchial epithelium by iPS and ALI in order to validate our model of study of the human bronchial epithelium COPD generated by the iPS. * Inducing a "COPD-like" epithelial phenotype by exposing the bronchial epithelia generated from the iPS to a source of in vitro toxin (tobacco) and studying its effects by transcriptomic analysis via high-throughput sequencing (NGS) at key steps during the model. * Demonstrate the feasibility of obtaining iPS from peripheral blood sampling.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Bronchial biopsy | The bronchial biopsy is part of this study's inclusion criteria and is required during routine care for the patient. Bronchial fibroscopy is performed under general or local anesthesia. Biopsies are performed using forceps and according to current recommendations. One biopsy will be fixed immediately in RCL2 medium while the others (between 3 and 6) will be kept in isotonic saline and rapidly prepared for air-liquid-interface (ALI) cell culture. |
| PROCEDURE | Skin biopsy | The skin biopsy will be performed after local anesthesia by hypodermic injection of a 1% Xylocaine solution. A single sample of a skin fragment about 3 mm in diameter will be necessary. |
| PROCEDURE | Blood sample | The blood sample will be taken at the end of the cutaneous biospy, approximately 20 ml of blood will be collected. |
Timeline
- Start date
- 2017-08-07
- Primary completion
- 2022-03-09
- Completion
- 2022-03-09
- First posted
- 2017-06-08
- Last updated
- 2023-09-08
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03181204. Inclusion in this directory is not an endorsement.