Umbilical Mesenchymal Stromal Cells as Cellular Immunotherapy for Septic Shock

Launched by OTTAWA HOSPITAL RESEARCH INSTITUTE · Jul 22, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of special cells called mesenchymal stem cells (MSCs) as a potential treatment for septic shock, a serious condition that can occur when an infection leads to dangerously low blood pressure and organ failure. The researchers believe that MSCs can help reduce inflammation, clear infections, and promote healing. This trial follows an earlier study showing that MSCs are safe to use in patients with septic shock. Now, they are looking for volunteers to participate in a Phase II trial across several Canadian hospitals to see how well MSCs work compared to standard treatments.

To be eligible for the trial, participants must be at least 18 years old, be admitted to the intensive care unit due to septic shock, and have experienced cardiovascular organ failure related to an infection. They must also have at least one other organ failure, such as respiratory or kidney issues. Patients with certain other health problems or those whose doctors believe they might not survive the next 12 hours will not be included. Participants in the trial will receive careful monitoring and follow-up to assess the safety and effectiveness of the MSC treatment. This trial is an important step in finding new ways to help patients recover from severe infections and improve their chances of survival.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• A participant must meet all the following inclusion criteria at time of randomization to be eligible:
• • 1. At least 18 years of age AND
• • 2. Requirement for admission to the intensive care unit AND
• • 3. Index admission to the intensive care unit AND
• • 4. 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
• • 5. Clinician impression that cardiovascular organ failure is related to infection AND
• 6. 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:
• • 1. 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 \</= 200), OR high-flow nasal canula oxygen therapy (minimum total flow rate of 30 lpm and 40% FiO2); OR
• • 2. Hematological failure: platelet count of \</= 100 X 10\^9/L OR
• • 3. 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% increase in their baseline creatinine concentration OR
• • 4. 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.
• Exclusion Criteria:
• Patients will be excluded if they have at least one of the following at time of randomization:
• • 1. Another form of shock (cardiogenic, hypovolemic, obstructive) OR
• • 2. History of known chronic pulmonary hypertension with a WHO functional class of IV OR
• • 3. History of severe chronic pulmonary disease requiring home oxygen OR
• • 4. 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 Cardiovascular Society angina class score IV OR
• • 5. History of severe chronic liver disease (Child-Pugh Class C or model for end stage liver disease (MELD) Score \>= 15) OR
• • 6. Malignancy in previous 1 year (excluding resolved non-melanoma skin cancer) OR
• • 7. Treating physician impression that death is imminent within the 12 hours after meeting eligibility criteria OR
• • 8. Pregnant or lactating OR
• • 9. Family or patient not committed to aggressive care