SepsisREPROCELLNCT07812012
The Potential of Mesenchymal Stromal Stem Cells to Correct Immune and Metabolic Dysfunctions in Circulating Immune Cells During Sepsis: An Ex Vivo Pilot Study.
An observational study of Sepsis, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Blood sample
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2026to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with sepsis complicated by ARDS or septic shock
Who may be able to join
- 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
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- 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
Who cannot join
- 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,
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU Dijon Bourgogne
Dijon, 21000
Marine JACQUIER, 0380293751 ext. +33, marine.jacquier@chu-dijon.fr
About this study
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.
Read more
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.
- Conditions
- Sepsis
- Being tested
- Blood sample
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleBiological
Drawing an EDTA tube
Blood sampleBiological
Collection of 5 heparinized tubes
| Study group | Role | What they receive |
|---|---|---|
| Patient with sepsis complicated by ARDS or septic shock | Not described Receives: Biological: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812012
- Sponsor's protocol ID
- JACQUIER CRBFC 2023
- Acronym
- REPROCELL
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential of Mesenchymal Stromal Stem Cells to Correct Immune and Metabolic Dysfunctions in Circulating Immune Cells During Sepsis: An Ex Vivo Pilot Study.
- ClinicalTrials.gov ID
- NCT07812012
- Acronym / sponsor ID
- REPROCELL / JACQUIER CRBFC 2023
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with sepsis complicated by ARDS or septic shock | – | Biological: Blood sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with sepsis complicated by ARDS or septic shock
Key inclusion criteria (16 listed)
- Patient or authorized representative, informed and having given consent
- Age ≥ 18 years
- Patients admitted for sepsis defined by the association as:
- Complicated
- Blood sample may be collected within 72 hours of admission to the intensive care unit
Key exclusion criteria (14 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleDrawing an EDTA tube | Biological | Patient with sepsis complicated by ARDS or septic shock |
| Blood sampleCollection of 5 heparinized tubes | Biological | Patient with sepsis complicated by ARDS or septic shock |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marine JACQUIER (0380293751 ext. +33, marine.jacquier@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.