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Phase I, randomized, parallel group, placebo control, unicentric, interventional study. Thirty two healthy male volunteers aged between 18-35 years will be randomized into the eASCs or placebo group if they meet all the inclusion criteria at a 3:1 ratio.
The treatment administration will be infused intravenously to the following groups after randomization:
An hour after the end of the eASCs administration, all subjects will be given an intravenous dose of LPS. Subjects will be allowed to leave in the evening once deemed clinically stable by the investigator.
Medicinal product Suspension of expanded adipose-derived allogeneic adult stem cells (eASCs) at a single dose of 250,000 cells/kg, 1 million cells/kg or 4 million cells/kg by intravenous infusion after suspension in Ringer's lactate solution.
Control Placebo (Ringer's lactate solution) Objectives To investigate the effect of eASCs on the inflammatory response to intravenous LPS in humans.
Design Phase I, randomized, parallel group, placebo control, unicentric, interventional study. Thirty two healthy male volunteers aged between 18-35 years will be randomized into the eASCs or placebo group if they meet all the inclusion criteria at a 3:1 ratio.
The treatment administration will be infused intravenously to the following groups after randomization:
An hour after the end of the eASCs administration, all subjects will be given an intravenous dose of LPS. Subjects will be allowed to leave in the evening once deemed clinically stable by the investigator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First arm | Experimental | 250,000 cells/kg will be administered via intravenous infusion. |
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| Second arm | Experimental | 1,000,000 cells/kg will be administered via intravenous infusion. |
|
| Third arm | Experimental | 4,000,000 cells/kg will be administered via intravenous infusion. |
|
| Fourth arm | Placebo Comparator | Placebo (Ringer's lactate solution) volume according to subject's weight. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous infusion of cells | Other | The treatment administration will be infused intravenously to the subjects after randomization: An hour after the end of the eASCs administration, all subjects will be given an intravenous dose of LPS. Subjects will be allowed to leave in the evening once deemed clinically stable by the investigator. |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory response as measured by laboratory measurements and functional assays of innate immunology | To investigate the effect of eASCs on the inflammatory response to intravenous LPS in humans. | Change from baseline markers up to 10 hours after LPS injection |
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Inclusion Criteria:
A subject will be eligible for inclusion in this study only if all of the following criteria apply:
Exclusion Criteria:
Subjects meeting any of the following exclusion criteria are not to be enrolled in the study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Medical Center | Amsterdam | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30063804 | Derived | Perlee D, van Vught LA, Scicluna BP, Maag A, Lutter R, Kemper EM, van 't Veer C, Punchard MA, Gonzalez J, Richard MP, Dalemans W, Lombardo E, de Vos AF, van der Poll T. Intravenous Infusion of Human Adipose Mesenchymal Stem Cells Modifies the Host Response to Lipopolysaccharide in Humans: A Randomized, Single-Blind, Parallel Group, Placebo Controlled Trial. Stem Cells. 2018 Nov;36(11):1778-1788. doi: 10.1002/stem.2891. Epub 2018 Aug 20. |
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|
| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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