Umbilical Mesenchymal Stromal Cells as Cellular Immunotherapy for Septic Shock

Sponsor
Ottawa Hospital Research Institute
Study ID
NCT05969275
Phase
PHASE2
Status
Recruiting
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Conditions

  • Infections
  • Inflammation
  • Pathologic Processes
  • Sepsis
  • Septic Shock
  • Shock
  • Systemic Inflammatory Response Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Allogeneic umbilical cord-derived human mesenchymal stromal cells — BIOLOGICAL
    Intravenous infusion of 300 million allogeneic, cryopreserved, umbilical cord-derived human mesenchymal stromal cells
  • Placebo — OTHER
    Intravenous infusion of placebo, with excipients

Study Details

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).

Key Dates

First listed
Aug 1, 2023
Start date
Feb 14, 2024
Status verified
Dec 2024
Primary completion
Sep 30, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
296 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Umbilical Cord Mesenchymal Stromal Cells (UC-MSCs)
    Intravenous infusion of 300 million allogeneic, cryopreserved, umbilical cord-derived human mesenchymal stromal cells
  • Placebo Comparator: Placebo
    Intravenous infusion of placebo, with excipients

Primary Outcome Measure

Days free from mechanical ventilation and/or vasopressors and/or renal replacement therapy [ Time Frame: Through to 28 days post-randomization ]

Central Contacts

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