NL-OMON41050
Completed
Not Applicable
Phase I, randomized, parallel group, placebo control, unicentric, interventional study to assess the effect of expanded human allogeneic adipose-derived mesenchymal adult stem cells on the human response to lipopolysaccharide in human volunteers - CELLULA study
TigeniX0 sites32 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- blood poisening
- Sponsor
- TigeniX
- Enrollment
- 32
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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