Epithelial repair in COPD using patient-derived iPS cells

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

This will try using each patient's own iPS cells to repair damaged bronchial lining in people with COPD, smokers without COPD, and non-smoking controls.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Montpellier (other)
• Locations: 1 site (Montpellier, Hérault)
• Trial ID: NCT06755008 on ClinicalTrials.gov

What this trial studies

Researchers take bronchial samples by bronchoscopy and generate induced pluripotent stem (iPS) cells from participants, then use those cells before re-differentiation to test whether they can help repair airway epithelium in air-liquid interface (ALI) cultures. The project compares epithelial repair capacity and timing across three groups: COPD patients, smokers without COPD, and non-smoker controls. Investigators will examine whether grafted iPS-derived cells contribute to restored epithelial cell composition and function in the ALI model. The work aims to validate the ALI aggression model and determine feasibility of seeding iPS-derived epithelial cells for ex vivo repair.

Who should consider this trial

Good fit: Adults (≥18) who can undergo bronchoscopy, including COPD patients (FEV1/FVC < 0.7, current or former smokers ≥10 pack-years), smokers without COPD (≥10 pack-years, preserved spirometry), and never- or long-ago former smokers as controls.

Not a fit: People who cannot safely undergo bronchoscopy, who have active respiratory infection or unstable comorbidities that prevent obtaining viable bronchial samples, or who do not meet the spirometric smoking criteria are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this approach could enable use of a patient's own iPS-derived cells to restore healthier bronchial epithelium and potentially reduce airway obstruction in COPD.

How similar studies have performed: Laboratory groups have successfully made airway epithelium from iPS cells and used ALI models, but applying patient-derived iPS cells to ex vivo repair of COPD epithelium is mostly novel and not yet clinically established.

Eligibility criteria

General Inclusion Criteria

* 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.

Exclusion Criteria:

* 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).
* Individual currently enrolled in another research study with an ongoing exclusion period.
* 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.

Where this trial is running

Montpellier, Hérault

• University Hospital of Montpellier, Arnaud de Villeneuve Hospital — Montpellier, Hérault, France (RECRUITING)

Study contacts

• Principal investigator: Mathilde VOLPATO, MD — University Hospital, Montpellier
• Study coordinator: Isabelle VACHIER, PhD

Conditions: Pulmonary Disease, Chronic Obstructive, COPD, bronchial epithelium, iPS, repair, Club cell