RecruitingPhase 2

Umbilical Mesenchymal Stromal Cells as Cellular Immunotherapy for Septic Shock

Canada296 participantsStarted 2024-02-14

Plain-language summary

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. Our team has completed a Phase I dose escalation and safety clinical trial that evaluated MSCs in patients with septic shock. The Cellular Immunotherapy for Septic Shock Phase I (CISS) trial established that MSCs appear safe and that a randomized controlled trial (RCT) is feasible. Based on these data, the investigators have planned a phase II RCT (UC-CISS II) at several Canadian academic centres which will evaluate intermediate measures of clinical efficacy (primary outcome), as well as biomarkers, safety, clinical outcome measures, and a health economic analysis (secondary outcomes).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 \</= 200), OR high-flow nasal canula oxygen therapy (minimum total flow rate of 30 lpm and 40% FiO2); OR
✓. Hematological failure: platelet count of \</= 100 X 10\^9/L OR

Exclusion criteria

What they're measuring

Days free from mechanical ventilation and/or vasopressors and/or renal replacement therapy

Timeframe: Through to 28 days post-randomization

Trial details

NCT IDNCT05969275

SponsorOttawa Hospital Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-30

Contact for this trial

Josee Champagne

613-737-8899 UCCISS@ohri.ca

View on ClinicalTrials.gov More Septic Shock trials