Date: 2017-01-31
Type of information: Recruitment of the first patient
phase: 1b/2a
Announcement: recruitment of the first patient
Company: TiGenix (Belgium)
Product: Cx611
Action
mechanism: cell therapy. Cx611 is an intravenously-administered product of allogeneic expanded adipose-derived stem cells (eASC's). Patients suffering from severe sepsis display a much higher level and persistence of inflammation. Cx611, given its multi-dimensional immunomodulatory properties, may have the potential to modulate and restore the deregulated immune response in patients with severe community-acquired pneumonia.
Disease: severe sepsis in community-acquired pneumonia (CAP)
Therapeutic area: Infectious diseases
Country:
Trial details:
Latest
news: * On January 31, 2017, TiGenix announced that the first patient has been enrolled and treated in its Phase Ib/IIa clinical trial for Cx611 (SEPCELL) in the treatment of severe sepsis in community-acquired pneumonia (CAP). The SEPCELL trial focuses on patients with severe community-acquired bacterial pneumonia, admitted to intensive care units due to severe sepsis, requiring mechanical ventilation and/or vasopressors. This study is a multicenter, international clinical trial to evaluate Cx611 safety profile at 90 days, the reduction in the duration of mechanical ventilation and/or vasopressors, as well as the overall survival rate, clinical cure, and other efficacy-related endpoints. Enrolled patients will receive one dose of either Cx611 or placebo on days one and three - total two doses - in addition to the standard of care.
Along with TiGenix, the SEPCELL project is represented by a group of five European research institutes that bring together the necessary competencies, expertise and resources to achieve the project's goals. SEPCELL has been awarded a €5.4 million grant by the European Union under the Horizon 2020 Research and Innovation Programme under Grant Agreement 681031.
