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Umbilical Mesenchymal Stromal Cells as Cellular Immunotherapy for Septic Shock
Sponsor: Ottawa Hospital Research Institute
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).
Official title: Umbilical Mesenchymal Stromal Cells as Cellular Immunotherapy for Septic Shock: A Multi-Center, Double Blind, Phase II Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
296
Start Date
2024-02-14
Completion Date
2027-03-31
Last Updated
2024-12-05
Healthy Volunteers
No
Conditions
Interventions
Allogeneic umbilical cord-derived human mesenchymal stromal cells
Intravenous infusion of 300 million allogeneic, cryopreserved, umbilical cord-derived human mesenchymal stromal cells
Placebo
Intravenous infusion of placebo, with excipients
Locations (2)
The Ottawa Hospital (General Campus)
Ottawa, Ontario, Canada
The Ottawa Hospital (Civic Campus)
Ottawa, Ontario, Canada