Cellular Immunotherapy for Septic Shock: A Phase I Trial

NCT02421484 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2018-10-31

No results posted yet for this study

Summary

This is a Phase I open label dose escalation trial of human allogeneic bone marrow derived mesenchymal stromal cells (MSCs) for the treatment of septic shock. The main purpose of the study is to assess the safety of MSCs in patients with septic shock.

Conditions

  • Septic Shock

Interventions

BIOLOGICAL

Allogeneic mesenchymal stromal cells

The allogeneic mesenchymal stromal cells will be administered intravenously.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV
  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Lauralyn McIntyre, MD · Ottawa Hospital Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-06-30
Completion
2018-10-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02421484 on ClinicalTrials.gov