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: * First arm: 250,000 cells/kg * Second arm: 1 million cells/kg * Third arm: 4 million cells/kg * Fourth arm: placebo according to their weight. 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: * First arm: 250,000 cells/kg * Second arm: 1 million cells/kg * Third arm: 4 million cells/kg * Fourth arm: placebo according to their weight. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
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.
Academic Medical Center
Amsterdam, Netherlands
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.
Time frame: Change from baseline markers up to 10 hours after LPS injection
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