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Csm-Gw

This article discusses a clinical trial investigating the use of CSM-GW, a type of mesenchymal stem cell (MSC), in treating patients with severe septic shock. The study aims to determine how these stem cells, when administered early in the course of septic shock, affect organ failure and patient outcomes. This Phase II trial compares the effects of CSM-GW to a control group, focusing on patients with community-acquired septic shock and multiple organ failures.

Table of Contents

What is CSM-GW?

CSM-GW is an experimental medication that contains mesenchymal stem cells (MSCs). These are special cells that can develop into different types of tissues in the body. The specific MSCs used in CSM-GW are derived from Wharton’s Jelly, which is a gelatinous substance found in the umbilical cord[1]. This medication is currently being studied as a potential treatment for a severe condition called septic shock.

What condition does CSM-GW treat?

CSM-GW is being investigated for the treatment of severe septic shock. Septic shock is a life-threatening condition that occurs when your body’s response to an infection causes widespread inflammation and organ failure. It’s considered severe when it leads to at least two organ failures (not including the circulatory system) within 12 hours of onset[1].

Symptoms of severe septic shock may include:

  • Difficulty breathing
  • Confusion or altered mental state
  • Decreased urine output
  • Low platelet count
  • Liver problems

How does CSM-GW work?

While the exact mechanism is still being studied, mesenchymal stem cells like those in CSM-GW are believed to have anti-inflammatory and tissue-repairing properties. In the case of septic shock, these cells might help to:

  • Reduce excessive inflammation in the body
  • Support the repair and regeneration of damaged organs
  • Modulate the immune system’s response to the infection

By potentially addressing these aspects, CSM-GW aims to improve organ function and overall outcomes for patients with severe septic shock[1].

How is CSM-GW administered?

CSM-GW is given as an intravenous injection, which means it’s delivered directly into the bloodstream through a vein. The medication comes in the form of a suspension for injection. In the current clinical trial, patients receive a single dose of 1 million cells per kilogram of body weight (with a slight variation allowed), up to a maximum of 80 million cells[1].

Current Clinical Trial

CSM-GW is currently being studied in a Phase II clinical trial called CHOC-MSC. This trial aims to determine the effects of mesenchymal stem cells when given in the early stages of septic shock. The main goals of the study include:

  1. Assessing how CSM-GW affects organ failure, as measured by a score called SOFA (Sepsis Organ Failure Assessment)[1].
  2. Determining if CSM-GW can help patients recover from organ failure more quickly[1].
  3. Evaluating the impact of CSM-GW on patient survival rates and length of stay in intensive care[1].
  4. Studying the safety of CSM-GW both immediately after injection and up to 3 months later[1].

Potential Benefits

If successful, CSM-GW could potentially offer several benefits for patients with severe septic shock:

  • Improved organ function
  • Faster recovery from organ failure
  • Reduced mortality rates
  • Shorter stays in intensive care

However, it’s important to note that these potential benefits are still being investigated and have not yet been proven[1].

Safety Considerations

As with any experimental treatment, there are potential risks and side effects associated with CSM-GW. The clinical trial is closely monitoring for any adverse events, including:

  • Temporary decrease in blood oxygen levels
  • Increase in pulmonary artery pressure
  • Shivering or fever
  • Pulmonary embolism (a blood clot in the lungs)

These potential side effects are being carefully watched for up to 2 hours after the injection of CSM-GW. The trial is also monitoring for any other adverse events for up to 90 days after treatment[1].

It’s crucial to understand that CSM-GW is still an investigational treatment. Its safety and effectiveness are not yet fully established, and it is not currently approved for general use outside of clinical trials.

Aspect Details
Drug Name CSM-GW (Mesenchymal Stem Cells)
Trial Phase Phase II
Condition Studied Severe community-acquired septic shock
Main Objective Effect on organ failure (SOFA score at Day 7)
Key Inclusion Criteria Adults with septic shock < 12 hours, ≥ 2 organ failures
Key Exclusion Criteria Nosocomial shock, immunosuppression, severe respiratory failure
Dosage 1 million cells/kg, max 80 million cells
Administration Intravenous injection
Safety Monitoring Immediate effects and adverse events up to 90 days

FAQ

  • What is CSM-GW and how is it used in this clinical trial? CSM-GW is a type of mesenchymal stem cell derived from Wharton's Jelly. In this trial, it is administered as a suspension for injection to patients with severe septic shock. The dose is 1 million cells per kilogram of body weight, with a maximum of 80 million cells.
  • Who is eligible to participate in this clinical trial? Eligible participants are adults (18 or older) with community-acquired septic shock for less than 12 hours, having at least two organ failures other than hemodynamic. The trial excludes patients with nosocomial septic shock, immunosuppression, or certain severe conditions.
  • What is the main objective of this clinical trial? The main objective is to determine how CSM-GW affects organ failure when given early in septic shock. This is measured using the SOFA (Sepsis Organ Failure Assessment) score at day 7, compared to a control group.
  • What are some of the secondary objectives of the trial? Secondary objectives include assessing the effect of CSM-GW on the time to improve organ function, its impact on individual organ failures, mortality rates at 28 and 90 days, length of stay in intensive care, and the safety profile of the treatment.
  • How is the safety of CSM-GW being evaluated in this trial? The trial monitors for immediate and short-term side effects, including changes in oxygen levels, pulmonary arterial pressure, fever, and the occurrence of pulmonary embolism. It also tracks adverse events up to 90 days after the CSM-GW injection.

Ongoing Clinical Trials on Csm-Gw

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

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

Glossary

  • Mesenchymal Stem Cells (MSCs): A type of stem cell that can develop into various cell types, including bone, cartilage, muscle, and fat cells. In this trial, they are being studied for their potential to reduce organ failure in septic shock.
  • Septic Shock: A life-threatening condition that occurs when sepsis leads to dangerously low blood pressure and abnormalities in cellular metabolism. It can cause multiple organ failure and requires immediate medical attention.
  • SOFA Score: Stands for Sepsis-related Organ Failure Assessment. It's a scoring system used to track a patient's status during their stay in an intensive care unit, measuring the function of six organ systems.
  • Community-acquired Septic Shock: Septic shock that develops from an infection acquired outside of a healthcare setting, as opposed to nosocomial (hospital-acquired) infections.
  • Organ Failure: A condition where an organ loses its ability to perform its normal functions. In septic shock, multiple organs can fail, including the lungs, kidneys, liver, and brain.
  • Catecholamines: Hormones produced by the adrenal glands, such as adrenaline and noradrenaline. In septic shock treatment, synthetic catecholamines are often used to maintain blood pressure.
  • PaO2/FiO2 Ratio: A measure of how well the lungs are transferring oxygen to the blood. It's calculated by dividing the partial pressure of oxygen in arterial blood by the fraction of inspired oxygen.
  • Extra-renal Purification: A method of filtering waste products from the blood when the kidneys are not functioning properly, also known as dialysis.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effects-of-mesenchymal-stem-cells-and-human-albumin-solution-on-organ-failure-in-patients-with-severe-septic-shock/