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

Completed

• Conditions: blood poisening; sepsis; 10019815

• Registration Number: NL-OMON41050
• Lead Sponsor: TigeniX

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 32

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Vital signs and symptoms and laboratory measurements that provide insight in<br /><br>induction of inflammatory responses.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable.</p><br>