blood poisening sepsis
Conditions
Interventions
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
8 subjects will receive Ringer*s lactate solution only).
Endotoxin (LPS): a single intravenous injection (2 ng/kg) in all 32 subjects.
Sponsors
TigeniX
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: See section 7.2.1 of the protocol. In brief: (1) healthy (based on a medical evaluation including medical history, physical examination, laboratory tests and ECG); (2) male aged between 18 and 35 years; (3) informed consent and able to comply with the requirements and restrictions listed in the informed consent form.
Exclusion criteria
Exclusion criteria: See section 7.2.2 of the protocol. In brief: (1) major illness in the past 3 months or any significant chronic medical illness; (2) history of malignancy; (3) use tobacco products; (4) history, within 3 years, of drug abuse; (5) history of alcoholism and/or drinking more than 5 units of alcohol per day; (6) any clinically relevant abnormality noted on ECG ; (7) use of investigational product within three months prior study; (8) use of prescription or non-prescription drugs and herbal and dietary supplements within 6 months; (9) transfusion of blood (products) within 6 months prior to the study; (10) difficultly in donating blood or accessibility of a vein in left or right arm; (11) donation of more than 350 mL of blood in last 3 months; (12) body mass index >28 kg/m2; (13) not able to comply with a study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital signs and symptoms and laboratory measurements that provide insight in induction of inflammatory responses. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not applicable. | — |
Countries
Netherlands
Outcome results
None listed