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. (SCOOP)
Study of Satellite Cells in COPD-associated sarcOPenia (Satellite Cells in COPD Sarcopenia) : Exploratory Cohort Study for Translational Research
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. To this end, the team will perform an exhaustive evaluation of lung and muscle function, including exercise capacity, as well as muscle biopsies, before and after a 2-months rehabilitation program. This study should provide new therapeutic avenues for COPD-associated sarcopenia.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Chronic obstructive pulmonary disease (COPD) is now to be considered as a multimorbid disease, originating from a combination of several risk factors (respiratory events in childhood, exposure to inhaled particles, physical inactivity, etc.), and simultaneously affecting several organs. This multi-organ impairment is likely to arise from common biological processes such as systemic inflammation or repair failure. Studying these processes in an organ that is easily accessible to biopsy, such as skeletal muscle, can help in the overall management of COPD. Skeletal muscle wasting (or sarcopenia: loss of muscle mass and force) is also a major comorbidity in COPD, both frequent and associated to increased mortality. Muscle stem cells (satellite cells) are responsible for repairing skeletal muscle tissue after injury, notably after micro-lesions induced by exercise. However, they have been scarcely studied in COPD. In the present project, the team proposes to study repair abnormalities in skeletal muscle tissue by comparing the signalling pathways activated in satellite cells of patients with COPD, before and after a respiratory rehabilitation programme (20 sessions over 8 to 12 weeks). The team will carry out an exhaustive respiratory and muscular assessment at inclusion and at the end of the 20 sessions, evaluating in particular respiratory function and exercise capacity (Pulmonary Function Tests, cardio-pulmonary exercise testing with VO2max measurement, 6-minute walking test, handgrip test) as well as a quadricipital muscle biopsy with the modified Bergström's technique. Muscle biopsies will be used to culture satellite cells and assess their regenerative capacity in vitro, as well as to analyse dysregulated signalling pathways at the transcriptomic level with single-cell RNAsequencing. The results should help to identify new therapeutic avenues for the comprehensive management of multimorbid COPD.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Pauline HENROT, MD
- Telefonní číslo: +33(0)5 57 65 65 13
- E-mail: pauline.henrot@chu-bordeaux.fr
Studijní místa
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Créteil, Francie, 94000
- Hôpital Henri-Mondor
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Kontakt:
- Laurent BOYER, MD, PhD
- Telefonní číslo: +33(0)1 49 81 26 81
- E-mail: laurent.boyer@aphp.fr
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Paris, Francie, 75013
- Hôpital Pitié-Salpêtrière
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Kontakt:
- Romy RATSIHORIMANANA, MD
- Telefonní číslo: +33(0)1 42 16 77 99
- E-mail: romy.ratsihorimanana@aphp.fr
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Pessac, Francie, 33400
- CHU de Bordeaux
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Kontakt:
- Pauline HENROT, MD
- Telefonní číslo: +33(0)5 57 65 65 13
- E-mail: pauline.henrot@chu-bordeaux.fr
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Vrchní vyšetřovatel:
- Pauline HENROT, MD
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Adult male or female (age 18 years or older);
- Having a diagnosis of COPD according to the GOLD (Global Initiative for Lung Disease) 2024 criteria, i.e. a non-reversible bronchial obstruction in spirometry with a post-bronchodilator Tiffeneau coefficient < 70%;
- Less than or equal to 75 years of age;
- Must benefit from exercise retraining sessions or respiratory rehabilitation as part of the management of COPD;
- Person affiliated to or beneficiary of a social security scheme (excluding State Medical Aid (AME));
- Free, informed and written consent signed by the participant or by a third party (in the event of the participant's physical disability) and the investigator (no later than the day of inclusion and before any review required by the research).
Exclusion Criteria:
- Moderate or severe acute exacerbation of COPD, or acute intercurrent condition (e.g., infection) that has been ongoing or resolved for less than 4 weeks;
- Systemic corticosteroid therapy in progress or stopped for less than 4 weeks;
- Contraindication to respiratory rehabilitation: tight aortic stenosis, unstable heart failure, active thromboembolic disease, ventricular aneurysm, uncontrolled arrhythmias;
- Contraindication to muscle biopsy: acquired or innate haemostasis disorders, anticoagulant treatment or double anti-platelet aggregation; contraindication to lidocaine: known hypersensitivity, patients with recurrent porphyrias;
- Presence of a concomitant muscle pathology, innate (e.g., genetic myopathy) or acquired (e.g., myositis, progressive cancer);
- Pregnant or breastfeeding woman;
- Patient under guardianship or curatorship;
- Refusal to participate in the study.
Exclusion criteria:
- Hemostasis disorders.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Men or women (adults) with a diagnosis of COPD according to GOLD criteria
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Patients will undergo an exhaustive respiratory and muscular check-up (including quadridipital muscle biopsies) at inclusion and at the end of the respiratory rehabilitation program (a minimum of 20 sessions at a rate of 2 to 3 sessions per week for 8 to 12 weeks). |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in single-cell gene expression profile of muscle satellite cells after pulmonary rehabilitation
Časové okno: Day 1 (baseline, Visit 1) and Week 10 (± 2 weeks; Visit 2)
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Intra-individual comparison of messenger RNA (mRNA) expression in muscle satellite cells isolated from quadriceps muscle biopsies collected before and after the pulmonary rehabilitation programme. Satellite cells will be isolated and analysed using single-cell and single-nucleus RNA sequencing. The outcome is the change in the gene-expression profile, including differentially expressed genes and associated molecular signalling pathways, between baseline and the end of rehabilitation. |
Day 1 (baseline, Visit 1) and Week 10 (± 2 weeks; Visit 2)
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Pauline HENROT, University Hospital, Bordeaux
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Neurologické projevy
- Nemoci nervového systému
- Neuromuskulární projevy
- Patologické procesy
- Patologické stavy, anatomické
- Chronické onemocnění
- Atributy nemoci
- Nemoci dýchacích cest
- Plicní onemocnění
- Plicní onemocnění, obstrukční
- Atrofie
- Patologické stavy, příznaky a symptomy
- Příznaky a symptomy
- Plicní onemocnění, chronická obstrukční
- Sarkopenie
- Svalová atrofie
- Motorická aktivita
- Hnutí
- Muskuloskeletální fyziologické jevy
- Muskuloskeletální a nervové fyziologické jevy
- Cvičení
Další identifikační čísla studie
- CHUBX 2026/005
- 2026-A00609-42 (Jiný identifikátor: French National Agency for Safety of Medicines and Health Products)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
The data is available from Dr HENROT . An email can be sent to her so that she can contact the data manager and owner, the Bordeaux University Hospital. The data can be made available after contractual agreement.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- ICF
- CSR
Informace o lécích a zařízeních, studijní dokumenty
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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