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Cellular Immunotherapy for Septic Shock: A Phase I Trial (CISS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT02421484
First received: February 8, 2015
Last updated: January 10, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention Phase
Septic Shock Biological: Allogeneic mesenchymal stromal cells Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cellular Immunotherapy for Septic Shock: A Phase I Trial

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Number of adverse events as a measure of safety and tolerability [ Time Frame: 12 months ]
    A historical cohort that met CISS eligibility criteria were previously enrolled to compare the incidence of adverse events with the CISS interventional arm.


Enrollment: 9
Study Start Date: May 2015
Estimated Study Completion Date: June 2017
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: allogeneic mesenchymal stromal cells
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
The allogeneic mesenchymal stromal cells will be administered intravenously.

Detailed Description:
Septic shock is one of the most common and devastating health problems in the intensive care unit, with a mortality rate of approximately 40% and a staggering economic burden of approximately 4 billion dollars annually in Canada. Mesenchymal stromal cells (MSCs) may provide a promising new treatment avenue, as pre-clinical research has shown that these cells can modify a number of pathophysiological processes that are central to sepsis and greatly reduce rates of organ failure and death. This dramatic effect appears to be due to the ability of MSCs to modify the inflammatory cascade, augment tissue repair and enhance pathogen clearance. MSCs have been evaluated in randomized clinical trials including those with myocardial infarction, heart failure, neurological and metabolic disorders, hematological malignancies, and chronic obstructive pulmonary disease with no serious safety concerns. However, MSC therapy has not yet been evaluated in humans with septic shock. Prior to a randomized controlled trial to examine the efficacy of MSCs in septic shock, an evaluation of safety is necessary. The Cellular Immunotherapy for Septic Shock (CISS) trial is an open label Phase I dose escalation trial that will evaluate the safety of MSC therapy in this vulnerable population.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

A participant must meet all 5 inclusion criteria to be eligible:

  1. Admission to the Ottawa Hospital Intensive Care Unit
  2. 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
  3. 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%.
  4. 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
  5. 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

Exclusion Criteria:

  1. Another form of shock (cardiogenic, hypovolemic, obstructive) that is considered by the treating critical care physician as the dominant cause of shock
  2. History of known pulmonary hypertension with a WHO functional class of III or IV
  3. History of severe pulmonary disease requiring home oxygen
  4. 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
  5. History of severe liver disease (Child class C)
  6. Malignancy in the previous 2 years (excluding resolved non-melanoma skin cancer).
  7. Chronic immune suppression
  8. History of anaphylaxis
  9. Pregnant or lactating
  10. Enrolment in another interventional study
  11. Family, participant, or physician not committed to aggressive care
  12. Less than 18 years of age
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02421484

Locations
Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L9
Sponsors and Collaborators
Ottawa Hospital Research Institute
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Lauralyn McIntyre, MD Ottawa Hospital Research Institute
  More Information

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02421484     History of Changes
Other Study ID Numbers: 2014809
Study First Received: February 8, 2015
Last Updated: January 10, 2017
Individual Participant Data  
Plan to Share IPD: Undecided
Plan Description: The sample size of the interventional arm is very small and the sharing of individual data has privacy and confidentiality implications.

Keywords provided by Ottawa Hospital Research Institute:
Phase I clinical trial
stem cell
mesenchymal stromal cell
mesenchymal stem cell

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation

ClinicalTrials.gov processed this record on June 23, 2017