Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05969275

Umbilical Mesenchymal Stromal Cells as Cellular Immunotherapy for Septic Shock

Led by Ottawa Hospital Research Institute · Updated on 2024-12-05

296

Participants Needed

2

Research Sites

163 weeks

Total Duration

On this page

Sponsors

O

Ottawa Hospital Research Institute

Lead Sponsor

C

Canadian Institutes of Health Research (CIHR)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Umbilical Mesenchymal Stromal Cells as Cellular Immunotherapy for Septic Shock

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years old
  • Currently admitted to the intensive care unit
  • This is the first admission to the intensive care unit
  • Cardiovascular organ failure lasting at least 1 hour needing specific blood pressure medications (norepinephrine, phenylephrine, or vasopressin)
  • Doctor believes cardiovascular failure is due to infection
  • At least one other acute organ failure within 24 hours, such as respiratory failure needing mechanical ventilation or high-flow oxygen, low platelet count, acute kidney injury, or high blood lactate
  • Acute organ failures have not lasted more than 48 hours before meeting these criteria
Not Eligible

You will not qualify if you...

  • Having another type of shock like cardiogenic, hypovolemic, or obstructive shock
  • Known chronic pulmonary hypertension with severe symptoms (WHO class IV)
  • Severe chronic lung disease needing home oxygen
  • Severe chronic heart disease such as heart failure or ischemic heart disease with severe symptoms
  • Severe chronic liver disease (Child-Pugh Class C or MELD score 15 or higher)
  • Cancer diagnosed within the past year (except resolved non-melanoma skin cancer)
  • Doctor believes death is likely within 12 hours after eligibility
  • Pregnant or breastfeeding
  • Patient or family not willing to continue aggressive medical care

AI-Screening

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Trial Site Locations

Total: 2 locations

1

The Ottawa Hospital (General Campus)

Ottawa, Ontario, Canada, K1H 8L6

Actively Recruiting

2

The Ottawa Hospital (Civic Campus)

Ottawa, Ontario, Canada, K1Y 4E9

Actively Recruiting

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Research Team

J

Josee Champagne

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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