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news.TiGenix has selected TFS International (TFS) for the first clinical trial (SEPCELL) to use stem cell therapy in the treatment of severe sepsis secondary to severe community acquired pneumonia (sCAP).
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The SEPCELL project is a randomized, double-blind, placebo-controlled, Phase Ib/IIa study in severe sepsis secondary to severe CAP (sCAP).
Subjects in the trial must have sCAP requiring mechanical ventilation and/or vasopressors. The trial is expected to enroll 180 patients, and will be conducted at approximately 50 centers throughout Europe. Subjects will be randomized 1:1 to receive active investigational product or placebo on days 1 and 3. All patients will also be treated with the standard of care, which generally includes antibiotics and anti-inflammatory drugs.
The primary endpoint is the number, frequency and type of adverse events during a 90 day period. Secondary endpoints include the reduction in the duration of mechanical ventilation and/or vasopressors, overall survival, clinical cure of sCAP, and other infection-related endpoints.
This study will assess the safety and efficacy of expanded allogeneic adipose-derived stem cells (eASCs) delivered intravenously. TFS medical and operational expertise in sepsis studies and strong experience with hospital-based trials were decisive factors for TiGenix selecting TFS.
"TFS is proud to have been selected by TiGenix as their clinical development partner in this study. Our medical and operational expertise in sepsis studies and strong experience with hospital-based trials were decisive factors in our favor", states Patricia A. Mosher, EVP Clinical Development, at TFS.
"TFS is very well positioned to work with small- to midsized biopharma and can provide valuable support from the early planning stages throughout the entire clinical development process."
TiGenix chief medical officer Marie Paule Richard said: "TFS is exactly the mid-size global full services provider with the dynamism, expertise and track record of quality trials needed for our study. Our daily collaboration demonstrates that we selected the right partner for this study in severe sepsis, which was awarded a grant from the European Commission under Horizon 2020, the European Union’s framework programme for research and innovation."