Belgium-based bio-pharmaceutical company TiGenix has begun enrolment for its Phase Ib/IIa clinical trial of Cx611 (SEPCELL) to treat severe sepsis in patients with community-acquired pneumonia (CAP).
Cx611 is an intravenously administered product of allogeneic expanded adipose-derived stem cells (eASCs) designed to modulate and restore the deregulated immune response in patients with severe community-acquired pneumonia.
The multicentre, international Phase Ib/IIa trial will evaluate the Cx611 safety profile at 90 days, the decrease in the duration of mechanical ventilation and / or vasopressors, as well as the overall survival rate, clinical cure, and other efficacy-related endpoints.
TiGenix chief medical officer Marie Paule Richard said: "Cx611, with its immunomodulatory action, represents a novel approach to address severe sepsis.
"The SEPCELL trial will provide valuable information on the safety, tolerability and efficacy of Cx611 as a candidate for the treatment of patients with severe sepsis."
Sepsis is a condition that arises when the body injures its own tissues and organs in response to an infection.
The trial is expected to enrol 180 patients and will be conducted in multiple European centres in patients with severe community-acquired bacterial pneumonia, admitted to intensive care units due to severe sepsis.
It is claimed to have been designed to address the drawbacks of previous trials with precise inclusion and exclusion criteria, as well as a specific patient population.
Represented by a group of five European research institutes in addition to TiGenix, the SEPCELL project has received a grant of €5.4m from the European Union.