NCT02328612

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 Lipopolysaccharyde in Human Volunteers

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 Lipopolysaccharyde in Human Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Tigenix S.A.U. · Industry
• Sex: Male
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Sepsis

Interventions

Type	Name	Description
OTHER	Intravenous 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.

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2014-12-31
• Last updated: 2015-04-03

Locations

1 site across 1 country: Netherlands