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

NCT06755008 | Recruiting

• 1 other identifier: RECHMPL24_0012
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

COPD; bronchial epithelium; iPS; repair; Club cell

Outcome Measures

Primary Outcomes (1)

• The main objective is to evaluate the repair capacity of the bronchial epithelium of COPD subjects using the reconstituted bronchial epithelium model in air/liquid interface culture and the iPS model.

  Percentage of repair at 24 hours post-lesion of ALI cultures vs. the same ALI cultures "grafted with iPS". This percentage will be determined by the surface area of the culture reconstructed after scratching divided by the surface area initially scratched.

  Day 1

Secondary Outcomes (7)

• comparison of % repair of post-scratch cultures in the presence or absence of IPS between the 3 groups

  Day 2, Day 3 and day 7

• Comparison of transepithelial electrical resistances between groups

  Day 2, Day 3 and day 7

• Determining the proportion of GFP-tagged iPS cells vs. native cells in lesion repair:

  Day 2, Day 3 and day 7

• Phenotyping of native and GFP+ iPS populations by immunofluorescent labeling of different cell types (ciliated cells, mucus cells, club cells, basal cells)

  Day 2, Day 3 and day 7

• Comparison of the transcriptomic profile for each cell subtype obtained after sorting native cells and GFP+ iPS cells by flow cytometry.

  Day 2, Day 3 and day 7

Study Arms (3)

smoker with COPD

EXPERIMENTAL

Bronchial biopsy performed during a planned bronchial fibroscopy as part of their disease management.

Procedure: bronchial fibroscopy

smoker without COPD

ACTIVE COMPARATOR

Bronchial biopsy performed during a planned bronchial fibroscopy as part of their disease management.

Procedure: bronchial fibroscopy

healthy non-smoking subject

ACTIVE COMPARATOR

Bronchial biopsy performed during a planned bronchial fibroscopy as part of their disease management.

Procedure: bronchial fibroscopy

Interventions

bronchial fibroscopy PROCEDURE

2 bronchial biopsies will be taken during bronchial fibroscopy

healthy non-smoking subject; smoker with COPD; smoker without COPD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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).
• 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.
• 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.

You may not qualify if:

• Participant with extensive neoplastic disease.
• Participant with another progressive pulmonary condition (e.g., asthma, tuberculosis, interstitial lung disease, active or recent pulmonary infection).
• Participant consuming illicit drugs or alcohol.
• Individual deprived of liberty (by judicial or administrative decision, or under involuntary hospitalization).
• Participant with recent psychiatric disorders (e.g., involuntary hospitalization, mental health conditions preventing informed consent, or requiring immediate medical intervention).
• Adult under legal protection (e.g., guardianship, curatorship, or judicial protection).
• Participant unable to provide informed consent.
• Participant not fluent in French and without a trusted person to assist with comprehension.
• Participant not affiliated with or covered by a social security system.
• Pregnant or breastfeeding women.
• Participant refusing to provide consent after being informed.
• Participant unable or incapable of expressing consent.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University Hospital of Montpellier, Arnaud de Villeneuve Hospital

Montpellier, Hérault, 34295, France

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mathilde VOLPATO, MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabelle VACHIER, PhD

CONTACT

(0)467042020; isabelle.vachier@medbiomed.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional, cross-sectional and pathophysiological experimental study

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: January 1, 2025
• Study Start: February 19, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 12, 2026

Record last verified: 2026-05

Locations

FR (1)