Stem cells put to the test against Sepsis's immune chaos

NCT ID NCT07812012

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First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Sepsis is a life-threatening reaction to infection that can leave the immune system weakened long after the initial crisis. Researchers in Dijon are studying whether mesenchymal stromal stem cells can correct immune and metabolic problems in blood cells taken from adults with severe sepsis in intensive care. They will mix the cells with blood samples outside the body and measure how the immune cells respond, including levels of an inflammatory signal called TNF-alpha. The team also plans to test whether priming the stem cells toward a pro-inflammatory or anti-inflammatory state could allow a more personalized approach.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mesenchymal stromal stem cells added to blood samples outside the body
What this could lead to
If the cells correct immune problems in the lab, this could point toward a future cell therapy for sepsis and its lingering immune weakness.
What could go wrong
This is a small lab study on blood samples, not a treatment given to patients. Results in a dish often do not carry over to people, and priming the cells for a specific immune state may not work as hoped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 51 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patient with sepsis complicated by ARDS or septic shock

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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How to take part

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  1. The places running it

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Contacts and locations

Locations

  • CHU Dijon Bourgogne

    Dijon, 21000, France

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