Pulmonary Disease, Chronic ObstructiveRepCOPDiPSNCT06755008
Benefits of Epithelial Repair in COPD by Induced Pluripotent Stem Cells (iPS)
A study testing bronchial fibroscopy in people with Pulmonary Disease, Chronic Obstructive, run by University Hospital, Montpellier at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- bronchial fibroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 19 Feb 2025to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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).
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital of Montpellier, Arnaud de Villeneuve Hospital
Montpellier, Hérault, 34295
Mathilde VOLPATO, MD, (0) 4 67 04.20.20 ext. +33, m-volpato@chu-montpellier.fr
About this study
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:
Read more
- 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.
Read the detailed description
Recently, the research team were able to show that there is a deficiency in a particular subtype of club cells destined to become ciliated in COPD, which would explain the inversion of the ciliated cell/caliciform cell ratio and therefore in the formation of the mucous plugs involved in bronchiolar obstruction.
iPS (induced pluripotent stem cells) represent a major biological breakthrough that has been awarded a Nobel Prize. They offer the advantage of being pluripotent, capable of multiplying endlessly, and thus of differentiating into any other cell type, or even organ, in short, embryogenesis. Researchers have developed a protocol for differentiating iPS cells into bronchial epithelia, with interesting success. These epithelia reconstituted in an air-liquid interface (iALI) reproduce all the characteristics of epithelia in vivo, in particular with the presence of all cell subtypes.
The research team hypothesizes that a patient's iPS cells, used before the re-differentiation stage, will enable ex vivo repair of his damaged epithelium.
The expected results of this project will be to validate the in vitro model of epithelial cell aggression in air-liquid interface (ALI) cultures, and to determine the feasibility of seeding iPS-derived epithelial cells. ALI epithelia from COPD patients would repair better or even normally thanks to iPS.
Ultimately, this project could be a potential therapy targeting epigenetics, and why not a cell therapy.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- bronchial fibroscopy
- Keywords
- COPD, bronchial epithelium, iPS, repair, Club cell
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bronchial fibroscopyProcedure or surgery
2 bronchial biopsies will be taken during bronchial fibroscopy
| Study group | Role | What they receive |
|---|---|---|
| smoker with COPD | Experimental | Bronchial biopsy performed during a planned bronchial fibroscopy as part of their disease management. Receives: Procedure: bronchial fibroscopy |
| smoker without COPD | Active comparator | Bronchial biopsy performed during a planned bronchial fibroscopy as part of their disease management. Receives: Procedure: bronchial fibroscopy |
| healthy non-smoking subject | Active comparator | Bronchial biopsy performed during a planned bronchial fibroscopy as part of their disease management. Receives: Procedure: bronchial fibroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (7)
comparison of % repair of post-scratch cultures in the presence or absence of IPS between the 3 groups
Calculation of the percentage of repair at 48 hours, 72 hours and at 7 days post-scratch. This percentage will be determined by the surface area of the culture rebuilt after scratching divided by the surface area initially scratched.
Measured: Day 2, Day 3 and day 7
Comparison of transepithelial electrical resistances between groups
Verification of the integrity of the bronchial epithelium obtained by measuring the transepithelial electrical resistance. (expressed as Ω/cm2 at each time point).
Measured: Day 2, Day 3 and day 7
Determining the proportion of GFP-tagged iPS cells vs. native cells in lesion repair:
Cell density measurements (% GFP cells/total cells) by microscopy at each time point
Measured: 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)
immunofluorescence will be used to assess the density of basal, club, ciliated and caliciform cells; the release of key proinflammatory cytokines classically implicated in COPD will be assayed in the supernatant of these cultures.
Measured: 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.
Comparison of the transcriptomic profile by ANOVA analysis of the 10 most highly expressed genes between native cells and IPS cells.
Measured: Day 2, Day 3 and day 7
Comparison of transcriptomic profile between ungrafted and grafted ALI.
Comparison of the transcriptomic profile by ANOVA analysis of the 10 most highly expressed genes
Measured: Day 2, Day 3 and day 7
ciliated cell/caliciform ratio to check whether the deficient club cell subtype is restored by this technique
the ciliated cell/caliciform ratio
Measured: Day 2, Day 3 and day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start19 Feb 2025
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Interventional, cross-sectional and pathophysiological experimental study
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathilde VOLPATO, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755008
- Sponsor's protocol ID
- RECHMPL24_0012
- Acronym
- RepCOPDiPS
- Status last verified
- May 2026
- First submitted
- 5 Dec 2024
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Epithelial Repair in COPD by Induced Pluripotent Stem Cells (iPS)
- ClinicalTrials.gov ID
- NCT06755008
- Acronym / sponsor ID
- RepCOPDiPS / RECHMPL24_0012
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- COPD, bronchial epithelium, iPS, repair, Club cell
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 19 Feb 2025 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 1 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Recently, the research team were able to show that there is a deficiency in a particular subtype of club cells destined to become ciliated in COPD, which would explain the inversion of the ciliated cell/caliciform cell ratio and therefore in the formation of the mucous plugs involved in bronchiolar obstruction.
iPS (induced pluripotent stem cells) represent a major biological breakthrough that has been awarded a Nobel Prize. They offer the advantage of being pluripotent, capable of multiplying endlessly, and thus of differentiating into any other cell type, or even organ, in short, embryogenesis. Researchers have developed a protocol for differentiating iPS cells into bronchial epithelia, with interesting success. These epithelia reconstituted in an air-liquid interface (iALI) reproduce all the characteristics of epithelia in vivo, in particular with the presence of all cell subtypes.
The research team hypothesizes that a patient's iPS cells, used before the re-differentiation stage, will enable ex vivo repair of his damaged epithelium.
The expected results of this project will be to validate the in vitro model of epithelial cell aggression in air-liquid interface (ALI) cultures, and to determine the feasibility of seeding iPS-derived epithelial cells. ALI epithelia from COPD patients would repair better or even normally thanks to iPS.
Ultimately, this project could be a potential therapy targeting epigenetics, and why not a cell therapy.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Interventional, cross-sectional and pathophysiological experimental study
| Arm | Type | Receives |
|---|---|---|
| smoker with COPD | Experimental | Procedure: bronchial fibroscopyBronchial biopsy performed during a planned bronchial fibroscopy as part of their disease management. |
| smoker without COPD | Active comparator | Procedure: bronchial fibroscopyBronchial biopsy performed during a planned bronchial fibroscopy as part of their disease management. |
| healthy non-smoking subject | Active comparator | Procedure: bronchial fibroscopyBronchial biopsy performed during a planned bronchial fibroscopy as part of their disease management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bronchial fibroscopy2 bronchial biopsies will be taken during bronchial fibroscopy | Procedure or surgery | healthy non-smoking subject, smoker with COPD, smoker without COPD |
Primary outcome
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.
Time frame: Day 1
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.
7 secondary outcomes
comparison of % repair of post-scratch cultures in the presence or absence of IPS between the 3 groups
Time frame: Day 2, Day 3 and day 7
Comparison of transepithelial electrical resistances between groups
Time frame: Day 2, Day 3 and day 7
Determining the proportion of GFP-tagged iPS cells vs. native cells in lesion repair:
Time frame: 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)
Time frame: 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.
Time frame: Day 2, Day 3 and day 7
Comparison of transcriptomic profile between ungrafted and grafted ALI.
Time frame: Day 2, Day 3 and day 7
ciliated cell/caliciform ratio to check whether the deficient club cell subtype is restored by this technique
Time frame: Day 2, Day 3 and day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mathilde VOLPATO, MD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bronchial fibroscopy in people with Pulmonary Disease, Chronic Obstructive, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabelle VACHIER, PhD ((0)467042020 ext. +33, isabelle.vachier@medbiomed.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.