Stem cells put to the test against Sepsis's immune chaos
NCT ID NCT07812012
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
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About 51 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU Dijon Bourgogne
Dijon, 21000, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Two cheap blood ratios put to the test as sepsis death predictors
- Can a computer model speed up sepsis blood tests?
- Can the immune system reveal who will suffer kidney injury after sepsis?
- A routine calcium reading could reveal how sick a sepsis patient really is
- Can a blood protein flag sepsis before it strikes?