Cellular Immunotherapy for Septic Shock: A Phase I Trial

NCT02421484 | Completed Phase 1 DMC

• 1 other identifier: 2014809
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Phase I clinical trial; stem cell; mesenchymal stromal cell; mesenchymal stem cell

Outcome Measures

Primary Outcomes (1)

• Number of adverse events as a measure of safety and tolerability

  A historical cohort that met CISS eligibility criteria were previously enrolled to compare the incidence of adverse events with the CISS interventional arm.

  12 months

Study Arms (1)

allogeneic mesenchymal stromal cells

EXPERIMENTAL

This is a Phase 1 dose escalation clinical trial that constitutes 3 dose cohorts with 3 participants per cohort who will receive intravenous doses of allogeneic bone marrow derived allogeneic mesenchymal stromal cells--0.3 million cells/kg, 1.0 million cells/kg, and 3.0 million cells/kg. We will proceed from the lower dose to the next higher dose if there are no safety concerns for each cohort.

Biological: Allogeneic mesenchymal stromal cells

Interventions

Allogeneic mesenchymal stromal cells BIOLOGICAL

The allogeneic mesenchymal stromal cells will be administered intravenously.

allogeneic mesenchymal stromal cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admission to the Ottawa Hospital Intensive Care Unit
• Receipt of appropriate broad spectrum antibiotics for the suspected/confirmed infectious source and adequate source control according to the opinion of the treating critical care physician
• Within 24 hours of admission to the ICU, receipt of reasonable levels of fluid administration and resuscitation as indicated by:
• a central venous pressure of at least 8 mm Hg AND
• a central venous oxygen saturation of at least 70%.
• Cardiovascular failure that is present within the first 24 hours of admission to the ICU and that is present for at least 4 consecutive hours AND
• Deterioration or lack of improvement in at least 1 additional organ function, or organ hypoperfusion, as defined by the modified Multiple Organ Dysfunction Score (MODS). Criteria for organ dysfunction or organ hypoperfusion must be met within the first 24 hours of ICU admission

You may not qualify if:

• Another form of shock (cardiogenic, hypovolemic, obstructive) that is considered by the treating critical care physician as the dominant cause of shock
• History of known pulmonary hypertension with a WHO functional class of III or IV
• History of severe pulmonary disease requiring home oxygen
• History of severe cardiac disease with a New York Heart Association Functional Class of III or IV, or severe ischemic heart disease with a Canadian Cardiovascular Society angina class score of III or IV
• History of severe liver disease (Child class C)
• Malignancy in the previous 2 years (excluding resolved non-melanoma skin cancer).
• Chronic immune suppression
• History of anaphylaxis
• Pregnant or lactating
• Enrolment in another interventional study
• Family, participant, or physician not committed to aggressive care
• Less than 18 years of age

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L9, Canada

Location

Related Publications (1)

• McIntyre LA, Stewart DJ, Mei SHJ, Courtman D, Watpool I, Granton J, Marshall J, Dos Santos C, Walley KR, Winston BW, Schlosser K, Fergusson DA; Canadian Critical Care Trials Group; Canadian Critical Care Translational Biology Group. Cellular Immunotherapy for Septic Shock. A Phase I Clinical Trial. Am J Respir Crit Care Med. 2018 Feb 1;197(3):337-347. doi: 10.1164/rccm.201705-1006OC.

  PMID: 28960096 DERIVED

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Lauralyn McIntyre, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2015
• First Posted: April 20, 2015
• Study Start: May 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: October 30, 2018
• Last Updated: October 31, 2018

Record last verified: 2018-10

Locations

CA (1)