Dysfunctions of Human Muscle Stem Cells in Sepsis

NCT02789995 | Completed

• 2 other identifiers: 2015-015ID-RCB number : 2015-A01022-47
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 7

Brief Summary

Severe critical illness is often complicated by Intensive Care Unit - Acquired Weakness (ICU-AW), which is associated with increased in and post-ICU mortality, with delayed weaning from mechanical ventilation and with long-term functional. Several mechanisms have been incriminated in the pathophysiology of ICU-AW, but muscle regeneration has not been well investigated in this context, even though its involvement is suggested by the protracted functional consequences of ICU-AW. Recent data suggest that muscle regeneration could be impaired after sepsis, and that Mesenchymal Stem Cells (MSCs) treatment could improve the post-injury muscle recovery.

Conditions

Sepsis

Keywords

Intensive Care Unit - Acquired Weakness (ICU-AW)

Outcome Measures

Primary Outcomes (1)

• Muscle regenerative capacities

  The muscle regenerative capacity after sepsis would be assessed by the presence of anisocytosis, the proportion of small atrophic fibers, the proportion of endomysial fibrosis of the total muscle section area and the presence of calcified necrotic myofibers.

  3 years

Secondary Outcomes (2)

• Satellite cell dysfunction after sepsis

  3 years

• Regenerative capacities of Human satellite cells in presence of mesenchymal stem cells

  3 years

Study Arms (1)

Patients with and without sepsis

EXPERIMENTAL

Patients with sepsis, Patients with inflammatory disease without sepsis, Patients without inflammatory disease without sepsis. Human biological samples collected for research : * Blood sample * Muscle biopsy * Bone marrow sample (mesenchymal stem cells)

Procedure: Human biological samples

Interventions

Human biological samples PROCEDURE

Blood sample - Muscle biopsy - Bone marrow sample (mesenchymal stem cells)

Patients with and without sepsis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Affiliated or beneficiary of a social security system
• Informed consent to research :
• Consent from patient, Or consent from patient and close relative, Or non-objection from family for biological sample donation for research.
• Population 1 (sepsis) : Patients hospitalized in Intensive Care Unit, with intra-abdominal sepsis requiring emergency surgery.
• Population 2 (inflammatory condition with or without sepsis) : Brain dead patients scheduled for multi organ retrieval (2a) ; Patients with refractory cariogenic shock and requiring surgery for assistance with (2b).
• Population 3 (control) : Patients scheduled for intra-abdominal surgery.

You may not qualify if:

• Patient with preexisting neuromuscular disease
• Under 18 year-old
• Pregnancy..

Sponsors & Collaborators

• Institut Pasteur: lead

Study Sites (7)

Hopital Henri Mondor, Service de Réanimation chirurgicale polyvalente

Créteil, 94010, France

Location

Hôpital Pitié Salpétrière, Salle de surveillance post-interventionnelle, Accueil des Polytraumatisés

Paris, 75013, France

Location

Hôpital Pitié Salpêtrière, Anesthésie et Réanimation, Institut de Cardiologie

Paris, 75013, France

Location

Hôpital Pitié Salpêtrière, Service de Chirurgie Générale, Viscérale et Endocrinienne

Paris, 75013, France

Location

Hôpital Pitié Salpêtrière, Service de Chirurgie Hépatobiliaire et de Transplantation Hépatique

Paris, 75013, France

Location

Hôpital Pitié Salpêtrière, Service de réanimation chirurgicale polyvalente

Paris, 75013, France

Location

Hôpital Saint-Antoine, Département d'Anesthésie-réanimation

Paris, France

Location

Related Publications (2)

• Rocheteau P, Chatre L, Briand D, Mebarki M, Jouvion G, Bardon J, Crochemore C, Serrani P, Lecci PP, Latil M, Matot B, Carlier PG, Latronico N, Huchet C, Lafoux A, Sharshar T, Ricchetti M, Chretien F. Sepsis induces long-term metabolic and mitochondrial muscle stem cell dysfunction amenable by mesenchymal stem cell therapy. Nat Commun. 2015 Dec 15;6:10145. doi: 10.1038/ncomms10145.

  PMID: 26666572 BACKGROUND

• Duceau B, Blatzer M, Bardon J, Chaze T, Giai Gianetto Q, Castelli F, Fenaille F, Duarte L, Lescot T, Tresallet C, Riou B, Matondo M, Langeron O, Rocheteau P, Chretien F, Bougle A. Using a multiomics approach to unravel a septic shock specific signature in skeletal muscle. Sci Rep. 2022 Nov 5;12(1):18776. doi: 10.1038/s41598-022-23544-8.

  PMID: 36335235 DERIVED

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fabrice Chrétien

  Institut Pasteur

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: June 3, 2016
• Study Start: June 23, 2016
• Primary Completion: June 28, 2018
• Study Completion: June 28, 2018
• Last Updated: November 1, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)