Cellular Immunotherapy for Septic Shock: A Phase I Trial (CISS)
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ClinicalTrials.gov Identifier: NCT02421484 |
Recruitment Status :
Completed
First Posted : April 20, 2015
Last Update Posted : October 31, 2018
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Condition or disease | Intervention/treatment | Phase |
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Septic Shock | Biological: Allogeneic mesenchymal stromal cells | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 9 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Cellular Immunotherapy for Septic Shock: A Phase I Trial |
Study Start Date : | May 2015 |
Actual Primary Completion Date : | June 2016 |
Actual Study Completion Date : | October 30, 2018 |
Arm | Intervention/treatment |
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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.
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Biological: Allogeneic mesenchymal stromal cells
The allogeneic mesenchymal stromal cells will be administered intravenously. |
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A participant must meet all 5 inclusion criteria to be eligible:
- 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
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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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02421484
Canada, Ontario | |
The Ottawa Hospital | |
Ottawa, Ontario, Canada, K1H 8L9 |
Principal Investigator: | Lauralyn McIntyre, MD | Ottawa Hospital Research Institute |
Responsible Party: | Ottawa Hospital Research Institute |
ClinicalTrials.gov Identifier: | NCT02421484 |
Other Study ID Numbers: |
2014809 |
First Posted: | April 20, 2015 Key Record Dates |
Last Update Posted: | October 31, 2018 |
Last Verified: | October 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
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. |
Phase I clinical trial stem cell mesenchymal stromal cell mesenchymal stem cell |
Shock, Septic Shock Pathologic Processes Sepsis |
Infections Systemic Inflammatory Response Syndrome Inflammation |