Date: 2015-05-28
Type of information: Results
phase: 1
Announcement: results
Company: TiGenix (Belgium)
Product: Cx611
Action
mechanism: Cell therapy. Cx611 is an intravenously-administered product of allogeneic expanded adipose-derived stem cells (eASC\'s).
Disease: sepsis
Therapeutic area: Infectious diseases
Country: The Netherlands
Trial
details: In this phase I, randomized, parallel group, placebo control, unicentric, interventional study, 32 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. (NCT02328612)
Latest
news: * On May 28, 2015, TiGenix, an advanced biopharmaceutical company focused on developing and commercialising novel therapeutics from its proprietary platform of allogeneic, expanded adipose-derived stem cells in inflammatory and autoimmune diseases, announced that the results of its Phase I sepsis challenge trial of Cx611 confirm safety and tolerability. This Phase I trial was a proof of principle study designed to demonstrate the safety and the ability of Cx611 in modifying the inflammatory response in healthy volunteers challenged with a bacterial endotoxin (LPS). The trial was a placebo-controlled, parallel group study in which 32 healthy male volunteers were randomised to receive Cx611 (at 3 doses) or placebo in a ratio of 3:1 and followed for 24 hours. * On March 12, 2015, TiGenix announced that it has completed the treatment of 32 subjects in its Phase I trial of Cx611 in a sepsis challenge model. No serious adverse events have been reported. Full results will be announced in the second quarter of 2015. This trial, codenamed CELLULA, is designed to confirm the safety and demonstrate the anti-inflammatory effect of Cx611 on the sepsis-like clinical symptoms and immunological response elicited by an intravenous administration of a bacterial endotoxin (lipopolysaccharide) in healthy volunteers. The trial is a placebo-controlled dose-ranging study (3 doses of Cx611) in 32 healthy male volunteers. It is being conducted in the Academic Medical Center of the University of Amsterdam in the Netherlands, which is a centre of excellence for such trials. No serious adverse events have been reported. Complete study results are expected in the second quarter of 2015. * On December 10, 2014, TiGenix announced that the first subject has been entered into its Phase I trial of Cx611 in severe sepsis. This trial is a proof of principle study and is designed to demonstrate the efficacy of Cx611 in healthy volunteers challenged with a bacterial endotoxin (lipopolysaccharide) which elicits an inflammatory response inducing sepsis-like clinical symptoms. The trial is a placebo-controlled dose-ranging study (3 doses of eASC\'s) in which 32 healthy male volunteers will be randomised to receive Cx611 or placebo in a ratio of 3:1. Primary endpoints will be vital signs and symptoms, laboratory measures and functional assays of innate immunity. TiGenix expects to complete this study by the third quarter of 2015 and then to follow up with a phase II trial of Cx611 as an add-on therapy to the standard of care in patients with severe sepsis. * On June 30, 2014, TiGenix announced that it will develop its allogeneic stem cell product, Cx611, for patients suffering from severe sepsis. In animal models, eASCs (expanded Adipose derived Stem Cells) have been shown both to decrease pro-inflammatory mediators and increase anti-inflammatory mediators, and to have anti-microbial effects. As a result of this mechanism of action, Cx611 has demonstrated efficacy in significantly reducing mortality in two animal models of sepsis. TiGenix therefore believes that Cx611 has a potentially important role when combined with current standards of care in patients with severe sepsis. The company is working on the development plan of Cx611 in this indication with an Advisory Board of Professor Pierre-François Laterre, Dr. Bruno François (Service de Réanimation Polyvalente, Centre Hospitalier Universitaire, Limoges, France), Professor Sébastien Gibot (Service de Réanimation Médicale, Centre Hospitalier Universitaire, Nancy, France) and Professor Tom van der Poll (Department of Internal Medicine, Academic Medical Center, University of Amsterdam, The Netherlands). As well as additional animal model testing, TiGenix will start a randomised, placebo-controlled trial to test the mechanism of action of Cx611 in healthy volunteers challenged with a bacterial endotoxin (lipopolysaccharide), a potent pro-inflammatory constituent of the outer membrane of Gram-negative bacteria, which elicits a strong inflammatory response inducing sepsis-like clinical symptoms. TiGenix expects to complete this study by the third quarter of 2015 and follow up with a phase II trial of Cx611 as an add-on therapy to the standard of care in patients with severe sepsis.
