Cx611-0204 SEPCELL Study

Summary

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.

Timeline

Start

2017-01-30

Primary completion

2020-07-07

Completion

2020-07-07

Publications

• Laterre PF, Sanchez Garcia M, van der Poll T, Wittebole X, Martinez-Sagasti F, Hernandez G, Ferrer R, Caballero J, Cadogan KA, Sullivan A, Zhang B, de la Rosa O, Lombardo E, Francois B; SEPCELL Study Group. The safety and efficacy of stem cells for the treatment of severe community-acquired bacterial pneumonia: A randomized clinical trial. J Crit Care. 2024 Feb;79:154446. doi: 10.1016/j.jcrc.2023.154446. Epub 2023 Oct 31.
• Laterre PF, Sanchez-Garcia M, van der Poll T, de la Rosa O, Cadogan KA, Lombardo E, Francois B. A phase Ib/IIa, randomised, double-blind, multicentre trial to assess the safety and efficacy of expanded Cx611 allogeneic adipose-derived stem cells (eASCs) for the treatment of patients with community-acquired bacterial pneumonia admitted to the intensive care unit. BMC Pulm Med. 2020 Nov 25;20(1):309. doi: 10.1186/s12890-020-01324-2.

Drugs

Indications