Umbilical Mesenchymal Stromal Cells as Cellular Immunotherapy for Septic Shock

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).

Conditions

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

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

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Stem Cell Network

  collaborator OTHER

• Canadian Critical Care Trials Group

  collaborator OTHER

• Technische Universität Dresden

  collaborator OTHER

• Ottawa Hospital Research Institute

  lead OTHER

Principal Investigators

• Lauralyn McIntyre, MD · The Ottawa Hospital Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-14

Primary Completion

2026-09-30

Completion

2027-03-31

Countries

• Canada

Study Locations