Sepsis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERIntravenous infusion of cells
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.
Sponsors
Tigenix S.A.U.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
A subject will be eligible for inclusion in this study only if all of the following criteria apply: 1. Healthy, as determined by a responsible physician, based on a medical evaluation including medical history, physical examination and laboratory tests carried out within 28 days prior to administration of eASCs (if applicable) and LPS. A subject with a clinical abnormality or laboratory parameter outside the reference range may be included only if the investigator judges that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures 2. Male aged between 18 and 35 years, inclusive at the time of signing the informed consent 3. Male subjects (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in activity in which conception is possible while on study medication and for at least 28 days after taking the last dose of study medication 4. Must understand and voluntarily sign an informed consent form prior to the conduct of any study related assessment/procedures. Capable of giving written informed consent and able to comply with the requirements and restrictions listed in the informed consent form.
Exclusion criteria
Subjects meeting any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory response as measured by laboratory measurements and functional assays of innate immunology | Change from baseline markers up to 10 hours after LPS injection | To investigate the effect of eASCs on the inflammatory response to intravenous LPS in humans. |
Countries
Netherlands
Outcome results
None listed