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Study identifier: NCT05969275 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Umbilical Mesenchymal Stromal Cells as Cellular Immunotherapy for Septic Shock

Condition: Septic Shock · Sepsis · Pathologic Processes  ·  Sponsor: Ottawa Hospital Research Institute

PhasePhase 2
Planned participants296
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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).

This description comes directly from the study's public registry record.

Talk to the study team

Josee Champagne  ·  613-737-8899  ·  UCCISS@ohri.ca

Always discuss trial participation with your own doctor first.

Locations (2)

The Ottawa Hospital (General Campus)Ottawa, Ontario, CanadaRecruiting
The Ottawa Hospital (Civic Campus)Ottawa, Ontario, CanadaRecruiting

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Source record: clinicaltrials.gov/study/NCT05969275