Cellular Immunotherapy for Septic Shock: A Phase I Trial (CISS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02421484|
Recruitment Status : Active, not recruiting
First Posted : April 20, 2015
Last Update Posted : January 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Septic Shock||Biological: Allogeneic mesenchymal stromal cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cellular Immunotherapy for Septic Shock: A Phase I Trial|
|Study Start Date :||May 2015|
|Actual Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||June 2018|
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.
- 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.
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
|The Ottawa Hospital|
|Ottawa, Ontario, Canada, K1H 8L9|
|Principal Investigator:||Lauralyn McIntyre, MD||Ottawa Hospital Research Institute|