Chronic Obstructive Pulmonary Disease (COPD) Clinical Trials

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Benefits of Epithelial Repair in COPD by Induced Pluripotent Stem Cells (iPS)

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The aim of this interventional, cross-sectional and pathophysiological experimental study is to evaluate the potential of a patient's induced pluripotent stem (iPS) cells, used prior to the re-differentiation stage, to enable ex vivo repair of the injured epithelium in patients with chronic obstructive pulmonary disease (COPD), smokers without COPD and non-smoking controls. The main questions it aims to answer are: * to evaluate the repair capacity of bronchial epithelium in COPD subjects, using a model of bronchial epithelium reconstituted in air/liquid interface culture and the iPS model. * epithelia repair capacities in normal or aberrant situations, as well as the time required for this repair, and to determine the involvement of grafted iPS cells in epithelia repair in cultured control subjects, smokers without COPD and COPD patients. Researchers will compare 3 groups of participants (COPD patients, smokers without COPD and non-smokers without COPD) for epithelial repair efficacy between non-grafted ALI cultures and ALI cultures grafted with iPS cells, in order to assess their contribution to epithelial repair. Participants will undergo a bronchial fibroscopy (for clinical indications) with two additional biopsies specific to the study. This research could lead to breakthroughs in cell-based therapies for COPD, with long-term implications for epigenetic treatments and in vivo applications.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Male and female participants aged 18 years or older.

• Participants with a bronchoscopy indication determined by a pulmonologist (e.g., follow-up exploration, nodule investigation, hemoptysis, cough, sputum production, recurrent bronchitis, or differential diagnosis).

⁃ Group 1 Inclusion Criteria: COPD

• Current or former smokers (≥10 pack-years).

• Diagnosed with COPD: FEV1/FVC \< 0.7 (confirmed by spirometry available in the medical file within the past year).

⁃ Group 2 Inclusion Criteria: Smokers without COPD (n=10)

• Current or former smokers (≥10 pack-years).

• No obstructive ventilatory disorder identified by clinical examination and/or (FEV1/FVC \> 0.7 and FEV1 \> 70% of predicted values) confirmed by spirometry within the past year.

⁃ Group 3 Inclusion Criteria: Non-smoker controls (n=10)

• Never-smokers or former smokers who quit more than 10 years ago (\<10 pack-years).

• No obstructive ventilatory disorder identified by clinical examination and/or (FEV1/FVC \> 0.7 and FEV1 \> 70% of predicted values) confirmed by spirometry within the past year.

Locations
Other Locations
France
University Hospital of Montpellier, Arnaud de Villeneuve Hospital
RECRUITING
Montpellier
Contact Information
Primary
Isabelle VACHIER, PhD
isabelle.vachier@medbiomed.fr
(0)467042020
Time Frame
Start Date: 2025-02-19
Estimated Completion Date: 2028-01-01
Participants
Target number of participants: 50
Treatments
Experimental: smoker with COPD
Bronchial biopsy performed during a planned bronchial fibroscopy as part of their disease management.
Active_comparator: smoker without COPD
Bronchial biopsy performed during a planned bronchial fibroscopy as part of their disease management.
Active_comparator: healthy non-smoking subject
Bronchial biopsy performed during a planned bronchial fibroscopy as part of their disease management.
Sponsors
Leads: University Hospital, Montpellier

This content was sourced from clinicaltrials.gov