Chronic Obstructive Lung DiseaseCoStemCellsNCT05227547
Mapping and Characterization of Alveolar Cells During Smoking and Chronic Obstructive Disease
A study testing Thoracic resection surgery in people with Chronic Obstructive Lung Disease and Chronic Obstructive Pulmonary Disease, run by Centre Hospitalier Intercommunal Creteil at 4 sites in France.
Trial summary
To evaluate the regenerative capacities of mesenchymal cells composing the microenvironment of alveolar type 2 cells in a population of patients, undergoing thoracic surgery for suspected cancer, who are smokers with and without COPD compared to non-smokers patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Lung Disease, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Thoracic resection surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 4 sitesFrance
- Study dates
- 5 Oct 2022to 5 Oct 2030
- 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
- Age ≥ 18
- Patient undergoing lung resection surgery (lobectomy, pneumonectomy, segmentectomy) for cancer or suspected cancer
- Acceptance to participate in the protocol
- Affiliated to a social security plan
Who cannot join
- Chronic autoimmune disease
- Patient under guardianship or curators
- Neo-adjuvant chemotherapy
- History of thoracic radiotherapy
- Pregnant woman
- Minor patient
- Person not able to consent
- Person deprived of liberty
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 1 recruiting
- Recruiting
Rousseau-Bussac
Créteil, 94000
Gaelle ROUSSEAU-BUSSAC, MD, 01 45 17 50 00 ext. +33, Gaelle.RousseauBussac@chicreteil.fr
LAURENT BOYER, MD
- Active, not recruiting
Hopital Cochin
Paris, 75014
- Active, not recruiting
HEGP
Paris, 75015
- Active, not recruiting
Hopital Tenon
Paris, 75020
About this study
To evaluate the regenerative capacities of mesenchymal cells composing the microenvironment of alveolar type 2 cells in a population of patients, undergoing thoracic surgery for suspected cancer, who are smokers with and without COPD compared to non-smokers patients
Read the detailed description
Chronic obstructive pulmonary diseases (COPD) have a major public health impact, as evidenced by the 250 million patients affected by these diseases and the 50% 5-year mortality for severe stages of chronic obstructive pulmonary disease (COPD). One pathophysiological mechanism of COPD and emphysema is a depletion of alveolar progenitor cells inducing a loss of alveolar-reparation capacities after an aggression. The genesis of these alterations and the mechanisms involved remain unknown. Alveolar type 2 cells (AT2) are the alveolar epithelial progenitor cells. AT2 proliferate and differentiate into alveolar type 1 cells (AT1) which form the alveolar-capillary barrier, along with endothelial cells, through which respiratory gas exchanges take place. The proliferation and differentiation of AT2 into AT1 are under the control of mesenchymal cells and endothelial cells located in close proximity. Together these cells form the alveolar stem cell niche. The characteristics and interactions of the different cell populations have been well described during lung growth, in the normal adult lung or during pulmonary fibrosis; however, participants are poorly described during smoking exposure and chronic obstructive diseases.
- Being tested
- Thoracic resection surgery
- 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.
Thoracic resection surgeryOther
Patients undergoing thoracic resection surgery (pneumonectomy, lobectomy, segmentectomy) for cancer or suspected cancer, including smokers (active or ex-smokers) and non-smokers, with COPD and without COPD, and non-smoking patients.
| Study group | Role | What they receive |
|---|---|---|
| Thoracic resection surgery | Other | Smokers (active or ex-smokers) and non-smokers with COPD and without COPD undergoing thoracic resection surgery Receives: Other: Thoracic resection surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of alveolar organoids
Comparison of the number of alveolar organoids formed 21 days after culture of fibroblasts with alveolar type II cells between smokers with and without COPD and non-smoking patients
Measured: through study completion, an average of 3 years
Secondary outcomes (17)
Fibroblast proliferation capacity
Evaluated by their doubling time, number of cells collected compared to the number of cells seeded
Measured: through study completion, an average of 3 years
Differentiation into myofibroblasts
By immunofluorescence marking: number of alpha-smooth muscle actin (alpha-SMA) + cells compared to total cells
Measured: through study completion, an average of 3 years
Fibroblast migration capacity
Evaluated in Boyden chamber
Measured: through study completion, an average of 3 years
Modulated signaling pathways in isolated fibroblasts between groups
Evaluated by Ribonucleic acid (RNA) sequencing of fibroblasts
Measured: through study completion, an average of 3 years
Modulated signaling pathways in endothelial cells between groups
Evaluated byRibonucleic acid (RNA) sequencing of endothelial cells
Measured: through study completion, an average of 3 years
Evaluation of cytokines in fibroblasts supernatant
Evaluated by Luminex Assay
Measured: through study completion, an average of 3 years
Tumor progression
By studying the migration and invasion of tumor cells
Measured: through study completion, an average of 3 years
Identification of different cell types on total lung
Cell types composing the lung stem cell microenvironment measured by single cell analysis
Measured: through study completion, an average of 3 years
Severity of pulmonary emphysema,
Change of lung density assessed by computed tomography scan
Measured: At inclusion, every year, up to 5 years after surgery
Type of pulmonary emphysema
Assessed by computed tomography scan :
[centro-lobular or pan-lobular, para-septal]
Measured: At inclusion, every year, up to 5 years after surgery
Research of pulmonary biomarkers
Searched according to the results obtained during cell cultures (immunohistochemistry, immunofluorescence)
Measured: through study completion, an average of 3 years
Identification of biomarkers in the pre and postoperative circulating blood
Evaluated in laboratory by metagenomic analysis of 16s Ribonucleic acid (RNA) of bacteria for cluster analysis that correlate with lung injury and could be prognostic markers
Measured: through study completion, an average of 3 years
Identification of biomarkers in the intestinal microbiota
Evaluated in laboratory by metagenomic analysis of 16s Ribonucleic acid (RNA) of bacteria for cluster analysis that correlate with lung injury and could be prognostic markers
Measured: through study completion, an average of 3 years
Measurement of Forced expiratory volume at one second (FEV1)
Determine the relationship between respiratory disease phenotype and exercise impact by measurement of Forced expiratory volume at one second (FEV1)
Measured: through study completion, an average of 3 years
Measurement of Forced Vital Capacity (FVC )
Determine the relationship between respiratory disease phenotype and exercise impact by measurement of Forced Vital Capacity (FVC )
Measured: through study completion, an average of 3 years
Measurement of pulmonary diffusion capacity of CO (DLCO)
Determine the relationship between respiratory disease phenotype and exercise impact by measurement of pulmonary diffusion capacity of CO (DLCO)
Measured: through study completion, an average of 3 years
Measurement of CO transfer coefficient (KCO)
Determine the relationship between respiratory disease phenotype and exercise impact by measurement of CO transfer coefficient (KCO)
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start5 Oct 2022
- Primary completion5 Oct 2030 (estimated)
- Study completion5 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Lung DiseaseStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Collaborators
- Henri Mondor University Hospital, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05227547
- Sponsor's protocol ID
- CoStemCells
- Acronym
- CoStemCells
- Status last verified
- Aug 2025
- First submitted
- 4 Nov 2021
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping and Characterization of Alveolar Cells During Smoking and Chronic Obstructive Disease
- ClinicalTrials.gov ID
- NCT05227547
- Acronym / sponsor ID
- CoStemCells / CoStemCells
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Collaborators
- Henri Mondor University Hospital, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 5 Oct 2030 (estimated)
- Study completion
- 5 Oct 2030 (estimated)
- First posted
- 7 Feb 2022 (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.
To evaluate the regenerative capacities of mesenchymal cells composing the microenvironment of alveolar type 2 cells in a population of patients, undergoing thoracic surgery for suspected cancer, who are smokers with and without COPD compared to non-smokers patients
Detailed description
Chronic obstructive pulmonary diseases (COPD) have a major public health impact, as evidenced by the 250 million patients affected by these diseases and the 50% 5-year mortality for severe stages of chronic obstructive pulmonary disease (COPD). One pathophysiological mechanism of COPD and emphysema is a depletion of alveolar progenitor cells inducing a loss of alveolar-reparation capacities after an aggression. The genesis of these alterations and the mechanisms involved remain unknown. Alveolar type 2 cells (AT2) are the alveolar epithelial progenitor cells. AT2 proliferate and differentiate into alveolar type 1 cells (AT1) which form the alveolar-capillary barrier, along with endothelial cells, through which respiratory gas exchanges take place. The proliferation and differentiation of AT2 into AT1 are under the control of mesenchymal cells and endothelial cells located in close proximity. Together these cells form the alveolar stem cell niche. The characteristics and interactions of the different cell populations have been well described during lung growth, in the normal adult lung or during pulmonary fibrosis; however, participants are poorly described during smoking exposure and chronic obstructive diseases.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thoracic resection surgery | Other | Other: Thoracic resection surgerySmokers (active or ex-smokers) and non-smokers with COPD and without COPD undergoing thoracic resection surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18
- Patient undergoing lung resection surgery (lobectomy, pneumonectomy, segmentectomy) for cancer or suspected cancer
- Acceptance to participate in the protocol
- Affiliated to a social security plan
Key exclusion criteria (8 listed)
- Chronic autoimmune disease
- Patient under guardianship or curators
- Neo-adjuvant chemotherapy
- History of thoracic radiotherapy
- Pregnant woman
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 |
|---|---|---|
| Thoracic resection surgeryPatients undergoing thoracic resection surgery (pneumonectomy, lobectomy, segmentectomy) for cancer or suspected cancer, including smokers (active or ex-smokers) and non-smokers, with COPD and without COPD, and non-smoking patients. | Other | Thoracic resection surgery |
Primary outcome
Number of alveolar organoids
Time frame: through study completion, an average of 3 years
Comparison of the number of alveolar organoids formed 21 days after culture of fibroblasts with alveolar type II cells between smokers with and without COPD and non-smoking patients
17 secondary outcomes
Fibroblast proliferation capacity
Time frame: through study completion, an average of 3 years
Differentiation into myofibroblasts
Time frame: through study completion, an average of 3 years
Fibroblast migration capacity
Time frame: through study completion, an average of 3 years
Modulated signaling pathways in isolated fibroblasts between groups
Time frame: through study completion, an average of 3 years
Modulated signaling pathways in endothelial cells between groups
Time frame: through study completion, an average of 3 years
Evaluation of cytokines in fibroblasts supernatant
Time frame: through study completion, an average of 3 years
Tumor progression
Time frame: through study completion, an average of 3 years
Identification of different cell types on total lung
Time frame: through study completion, an average of 3 years
Severity of pulmonary emphysema,
Time frame: At inclusion, every year, up to 5 years after surgery
Type of pulmonary emphysema
Time frame: At inclusion, every year, up to 5 years after surgery
Research of pulmonary biomarkers
Time frame: through study completion, an average of 3 years
Identification of biomarkers in the pre and postoperative circulating blood
Time frame: through study completion, an average of 3 years
Identification of biomarkers in the intestinal microbiota
Time frame: through study completion, an average of 3 years
Measurement of Forced expiratory volume at one second (FEV1)
Time frame: through study completion, an average of 3 years
Measurement of Forced Vital Capacity (FVC )
Time frame: through study completion, an average of 3 years
Measurement of pulmonary diffusion capacity of CO (DLCO)
Time frame: through study completion, an average of 3 years
Measurement of CO transfer coefficient (KCO)
Time frame: through study completion, an average of 3 years
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 2 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Chronic Obstructive Lung Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic resection surgery in people with Chronic Obstructive Lung Disease and Chronic Obstructive Pulmonary Disease, run by Centre Hospitalier Intercommunal Creteil at 4 sites 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 4 inclusion and 8 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 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 JUNG Camille, MD (0145175000 ext. +33, camille.jung@chiccreteil.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of alveolar organoids (time frame: through study completion, an average of 3 years). 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 2 Sep 2025.