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New treatment option for Septic Shock
Official title Umbilical Mesenchymal Stromal Cells as Cellular Immunotherapy for Septic Shock
ClinicalTrials.gov ID: NCT05969275
What this study is testing
What is Allogeneic umbilical cord-derived human mesenchymal stromal cells?
Allogeneic umbilical cord-derived human mesenchymal stromal cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for septic shock.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Septic shock is associated with substantial burden in terms of both mortality and morbidity for survivors of this illness. Pre-clinical sepsis studies suggest that mesenchymal stem (stromal) cells (MSCs) modulate inflammation, enhance pathogen clearance and tissue repair and reduce death.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- A participant must meet all the following at time of randomization to be eligible:
- At least 18 years of age AND
- Requirement for admission to the intensive care unit AND
- Index admission to the intensive care unit AND
- Cardiovascular organ failure for at least 1 consecutive hour defined by the requirement of at least 5 mcg/min of norepinephrine or 100 mcg/min of...
You likely can't join if
- Patients will be excluded if they have at least one of the following at time of randomization:
- Another form of shock (cardiogenic, hypovolemic, obstructive) OR
- History of known chronic pulmonary hypertension with a WHO functional class of IV OR
- History of severe chronic pulmonary disease requiring home oxygen OR
- History of severe chronic cardiac disease including congestive heart failure or valvular dysfunction with a New York Heart Association Functional...
- History of severe chronic liver disease (Child-Pugh Class C or model for end stage liver disease (MELD) Score \>= 15) OR
See the full eligibility criteria
- A participant must meet all the following at time of randomization to be eligible:
- At least 18 years of age AND
- Requirement for admission to the intensive care unit AND
- Index admission to the intensive care unit AND
- Cardiovascular organ failure for at least 1 consecutive hour defined by the requirement of at least 5 mcg/min of norepinephrine or 100 mcg/min of phenylephrine or 0.03 U/min vasopressin AND
- Clinician impression that cardiovascular organ failure is related to infection AND
- There is at least 1 other acute organ failure according to modified individual Sequential Organ Failure Assessment Scores within 24 hours of meeting Cardiovascular organ failure defined by:
- Respiratory failure: invasive or non-invasive mechanical ventilation with a positive end expiratory pressure (PEEP) \>/= 5 cm H2O and a partial pressure of oxygen/fractional inspired oxygen concentration (P/F ratio \</=...
- Hematological failure: platelet count of \</= 100 X 10\^9/L OR
- Acute kidney injury: acute renal insufficiency with a creatinine of \>/= 200 umol/L, or the requirement for new renal replacement therapy, or for participants with known chronic renal failure but not on dialysis, a 50%...
- Organ hypoperfusion: a lactate \>/= 4 mmol/L Acute organ failures that meet eligibility criteria must not have been present for greater than 48 hours prior to meeting the eligibility criteria.
- Patients will be excluded if they have at least one of the following at time of randomization:
- Another form of shock (cardiogenic, hypovolemic, obstructive) OR
- History of known chronic pulmonary hypertension with a WHO functional class of IV OR
- History of severe chronic pulmonary disease requiring home oxygen OR
- History of severe chronic cardiac disease including congestive heart failure or valvular dysfunction with a New York Heart Association Functional class IV or severe chronic ischemic heart disease with a Canadian...
- History of severe chronic liver disease (Child-Pugh Class C or model for end stage liver disease (MELD) Score \>= 15) OR
- Malignancy in previous 1 year (excluding resolved non-melanoma skin cancer) OR
- Treating physician impression that death is imminent within the 12 hours after meeting eligibility criteria OR
- Pregnant or lactating OR
- Family or patient not committed to aggressive care
The study team makes the final eligibility decision.
Where it's taking place
- Ottawa, Ontario, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ottawa, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.