The Potential of Mesenchymal Stromal Stem Cells to Correct Immune and Metabolic Dysfunctions in Circulating Immune Cells During Sepsis: An Ex Vivo Pilot Study. (REPROCELL)

September 4, 2026 updated by: Centre Hospitalier Universitaire Dijon

Sepsis is a life-threatening organ dysfunction caused by the host's dysregulated immune response to infection. It represents a major global public health challenge. A state of post-septic compensatory immunosuppression may contribute to excess mortality by promoting secondary infections, thereby prolonging the stay in the intensive care unit and increasing the risk of death.

New therapeutic strategies to complement antimicrobial treatments-which may correct sepsis-induced functional alterations in immune cells (such as endotoxin tolerance and reduced HLA-DR expression), partly mediated by metabolic abnormalities-are currently being investigated. Among these, mesenchymal stromal cells (MSCs) appear particularly promising. They are capable of reprogramming immune cells by redirecting certain metabolic pathways, notably improving mitochondrial function. MSCs generally have an anti-inflammatory effect in preclinical models of infection, particularly in the early phase of severe ventilated pneumonia, as illustrated by the animal model we have developed, and preliminary trials are currently underway in humans. The ability of CSMs to correct sepsis-induced immunosuppression has not yet been explored. Nevertheless, CSMs possess the ability to communicate with the inflammatory microenvironment in which they are found, conferring plasticity to their response.

We hypothesize that CSMs could correct certain immune and metabolic dysfunctions in circulating immune cells from patients with sepsis meeting severity criteria who are admitted to the intensive care unit.

Furthermore, priming (or prior stimulation) of CSMs could enable a more precise and personalized therapeutic approach, with the possibility of directing CSMs toward a pro-inflammatory (CSM1) or anti-inflammatory (CSM2) phenotype through prior incubation with specific agonists (LPS; IFN-γ/TNF, respectively) before their administration. Depending on the patient's immune status (pro-inflammatory or anti-inflammatory phase), such a personalized approach would optimize treatment with CSMs.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient with sepsis complicated by ARDS or septic shock

Description

Inclusion Criteria:

  • Patient or authorized representative, informed and having given consent
  • Age ≥ 18 years

  • Patients admitted for sepsis defined by the association as:

    • Clinically or microbiologically documented infection

    • SOFA-2 score ≥ 2

      • Or +2 points if pre-existing organ dysfunction

  • Complicated

    • ARDS (Berlin criteria (1))

      • Acute respiratory failure
      • AND Bilateral pulmonary opacities (X-ray or CT scan) with no evidence of predominant hydrostatic edema
      • AND PaO₂/FiO₂ ≤ 300 mmHg under invasive or non-invasive ventilation with PEEP ≥ 5 cmH₂O

    • or septic shock (2)

      • Vasopressors required to maintain mean arterial pressure (MAP) ≥ 65 mmHg
      • AND arterial lactate > 2 mmol/L
      • AND despite adequate fluid resuscitation
  • Blood sample may be collected within 72 hours of admission to the intensive care unit

Exclusion Criteria:

  • Individuals not enrolled in or not eligible for a social security program
  • Individuals subject to a legal protection order
  • Pregnant women, women in labor, or breastfeeding women

  • Known severe immunodeficiency prior to sepsis:

    • cytostatic chemotherapy within the previous 3 months,
    • previously known neutropenia < 500/mm³ (within the past month) not attributed to sepsis,
    • active hematologic malignancy currently undergoing treatment,
    • allogeneic bone marrow transplant < 1 year ago,
    • solid organ transplant receiving immunosuppressants
    • corticosteroid therapy ≥ 0.5 mg/kg/day of prednisone equivalent for > 3 weeks,
    • anti-TNF or anti-IL-6 biologic therapy within the past 3 months,
    • HIV infection with a detectable viral load while not on treatment

Secondary exclusion criteria :

- A diagnosis of sepsis was ruled out following a comprehensive medical evaluation and/or an alternative diagnosis was identified that explains the elevated SOFA-2 score

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient with sepsis complicated by ARDS or septic shock
Biological: Blood sample
Drawing an EDTA tube
Biological: Blood sample
Collection of 5 heparinized tubes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Concentration of TNF-α in the supernatant from ex vivo co-incubation of whole blood collected on days 1-3 after admission to the intensive care unit (± CSMs), as measured by ELISA, following stimulation of immune cells with LPS
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

September 4, 2026

First Submitted That Met QC Criteria

September 4, 2026

First Posted (Actual)

September 10, 2026

Study Record Updates

Last Update Posted (Actual)

September 10, 2026

Last Update Submitted That Met QC Criteria

September 4, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JACQUIER CRBFC 2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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