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Study on the Effects of Mesenchymal Stem Cells and Human Albumin Solution on Organ Failure in Patients with Severe Septic Shock

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for patients experiencing a very severe form of septic shock. Septic shock is a serious condition that occurs when an infection leads to dangerously low blood pressure and organ failure. The treatment being tested involves the use of mesenchymal stem cells (MSCs), which are special cells that can develop into different types of cells and may help repair damaged tissues. The study will compare the effects of MSCs with other treatments, including human albumin solution, albumin, and sodium chloride.

The purpose of the study is to determine how MSCs affect the progression of organ failure in patients with septic shock. Participants in the study will receive the treatment within 12 hours of the onset of septic shock. The study will monitor the patients' health over a period of time to assess the impact of the treatment on their condition. The main focus will be on the Sepsis Organ Failure Assessment (SOFA) score, which is a measure used to track a patient's status during treatment. The study will also look at other factors, such as the number of days patients can live without needing respiratory support or other intensive care interventions.

Throughout the study, researchers will observe any changes in the patients' health, including potential side effects or improvements. The study aims to provide valuable information on whether MSCs can be an effective treatment for reducing organ failure in septic shock patients. This research could lead to new ways to help patients recover from this life-threatening condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, consent is required. If unable to provide consent, a close relative or trusted person may do so on your behalf. In life-threatening situations, immediate inclusion is possible.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to confirm eligibility. This includes verifying age, medical condition, and other criteria such as the presence of community-acquired septic shock for less than 12 hours.

  3. Step 3

    Treatment administration

    The treatment involves the administration of mesenchymal stem cells (MSCs) through an intravenous solution. This is done in the early phase of septic shock to assess its effect on organ failure.

  4. Step 4

    Monitoring and evaluation

    Monitoring occurs throughout the study to evaluate the effect of the treatment. The primary measure is the SOFA score, which assesses organ function. This is checked at day 7 or earlier if discharged or in the event of death.

    Secondary evaluations include the number of days without respiratory assistance, catecholamines, or extra-renal purification by day 28, as well as overall length of stay in intensive care and hospital.

  5. Step 5

    Follow-up

    Follow-up assessments are conducted to monitor any adverse events up to 90 days after the MSC injection. This includes checking for changes in respiratory function, blood pressure, and any other potential side effects.

Who can join the trial?

11 criteria

  • Patient must be 18 years or older.
  • For women under 60, a negative pregnancy test is required. Effective methods of contraception must be used until the end of the clinical trial.
  • Must have community-acquired septic shock for less than 12 hours. This means the condition started outside of a hospital and has been present for less than 12 hours.
  • Must have at least 2 organ failures other than blood pressure-related issues. This can include:
    • Respiratory failure: Difficulty in breathing, measured by specific tests.
    • Neurological failure: Reduced consciousness, measured by a score called the Glasgow score.
    • Kidney failure: Low urine output or high levels of a waste product called creatinine in the blood.
    • Blood-related issues: Low platelet count, which helps in blood clotting.
    • Liver failure: High levels of a substance called bilirubin in the blood.
    • Septic shock must occur after 8 p.m. between Sunday and Thursday. This is due to the availability of staff for the trial.
    • Patient must have given consent to participate, or consent must be obtained from a close relative or trusted person if applicable.
    • Patient must be affiliated with a Social Security scheme or be a beneficiary of such a scheme.

Who cannot join the trial?

3 criteria

  • Patients who have been in septic shock for more than 12 hours.
  • Patients with less than two organ failures other than blood pressure-related issues.
  • Patients who are not in intensive care.
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  • CHRU De Nancy

    Responsive

    FranceVandoeuvre Les Nancy, France

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Investigated drugs

Mesenchymal Stem Cells (MSC) are a type of cell therapy used in this clinical trial. These cells are special because they have the ability to develop into different types of cells in the body. In this study, they are being tested to see if they can help improve organ function in patients who are experiencing septic shock, a serious condition that can lead to organ failure. The goal is to see if these cells can help reduce the severity of organ failure when given early during septic shock.

What is already known about the treatment

Mesenchymal Stem Cells (MSC) – Mesenchymal stem cells are administered intravenously, meaning they are delivered directly into the bloodstream through a vein. Currently, MSCs are being studied in clinical trials to assess their potential benefits in treating severe community-acquired septic shock, a life-threatening condition where the body's response to infection causes organ failure. The main therapeutic indication for MSCs in this trial is to improve organ function in patients experiencing septic shock. At the molecular level, MSCs are believed to work by modulating the immune response and reducing inflammation, which may help protect and repair damaged tissues. They are classified as a type of cell-based therapy, which involves using living cells to treat or manage diseases.

Investigated diseases

Septic Shock – Septic shock is a severe and widespread infection that leads to dangerously low blood pressure and organ dysfunction. It begins with an infection that triggers an overwhelming immune response, causing inflammation throughout the body. As the condition progresses, it can lead to multiple organ failures, including the heart, lungs, and kidneys. The body's blood vessels may become leaky, and blood flow to vital organs can be compromised. This can result in a significant drop in blood pressure, known as hypotension, which is resistant to fluid replacement. If not managed promptly, septic shock can lead to severe complications and further deterioration of organ function.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518019-20-00Estimated enrolment66 patientsSponsorCHRU De Nancy

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