Last updated on February 2018

Cx611-0204 SEPCELL Study


Brief description of study

The purpose of this randomised, multicentre, double-blind, placebo-controlled, phase Ib/IIa study is to assess the safety, tolerability and efficacy of eASCs (Cx611) administered intravenously as adjunctive therapy, therefore in addition to standard of care (SoC) therapy, to patients with severe community-acquired bacterial pneumonia (sCABP).

The completion of this study will contribute to the basic knowledge on stem cells and their mode-of-action, and has a large translational character, i.e. to document the safety and explore the efficacy of Cx611 in patients with sCABP.

Detailed Study Description

The purpose of this randomised, multicentre, double-blind, placebo-controlled, phase Ib/IIa study is to assess the safety, tolerability and efficacy of eASCs (Cx611) administered intravenously as adjunctive therapy, therefore in addition to standard of care (SoC) therapy, to patients with severe community-acquired bacterial pneumonia (sCABP).

The key objectives of this study are to:

Primary objective:

Investigate the safety profile of two allogeneic Cx611 central line 80 mL infusions within 3 days (on days 1 and 3) at a dose of 160 million cells each (320 million cells total) and to monitor any adverse event and potential immunological host responses against the administered cells during 90 days of follow-up after the first infusion.

Secondary objectives:

  1. Explore the clinical efficacy of Cx611 in terms of a reduction of the duration of mechanical ventilation and/or need for vasopressors and/or improved survival, and/or clinical cure of the sCABP, and other efficacy-related endpoints.
  2. Understand the mode-of-action of Cx611 in patients with sCABP by identifying the pro-inflammatory and anti- inflammatory pathways through which Cx611 may affect the underlying processes of sepsis.
  3. Follow-up safety (only SAEs) at months 6 and 12 after the first investigational medicinal product (IMP) dose administration (Day 1).

Exploratory objective:

Safety data collection (SAEs collection via phone calls) at months 18 and 24. The completion of this study will contribute to the basic knowledge on stem cells and their mode-of-action, and has a large translational character, i.e. to document the safety and explore the efficacy of Cx611 in patients with sCABP. The study results will be critical for the design of further confirmatory clinical trials in terms of definition of endpoints, key biomarkers and sample size determination.

Clinical Study Identifier: NCT03158727

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Thierry DUGERNIER, MD

Clinique Saint-Pierre
Ottignies, Belgium
8.56miles
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