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RECRUITING
NCT05969275
PHASE2

Umbilical Mesenchymal Stromal Cells as Cellular Immunotherapy for Septic Shock

Sponsor: Ottawa Hospital Research Institute

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

Allogeneic umbilical cord-derived human mesenchymal stromal cells

Intravenous infusion of 300 million allogeneic, cryopreserved, umbilical cord-derived human mesenchymal stromal cells

OTHER

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