• Pierre-François Laterre, Sánchez GarcíaMiguelMCritical Care Department, Hospital Clínico San Carlos, Madrid, Spain., Tom van der Poll, Xavier Wittebole, Fernando Martínez-Sagasti, Gonzalo Hernandez, Ricard Ferrer, Jesus Caballero, Kathy-Ann Cadogan, Adam Sullivan, Barbara Zhang, Olga de la Rosa, Eleuterio Lombardo, Bruno François, and SEPCELL Study Group.
• Department of Intensive Care Medicine, CHR Mons-Hainaut, Mons, Belgium. Electronic address: pierrefrancoislaterre@gmail.com.
• J Crit Care. 2024 Feb 1; 79: 154446154446.

PurposeEvaluate the safety profile of expanded allogeneic adipose-derived mesenchymal stem cell (eASC) for the treatment of severe community-acquired bacterial pneumonia (CABP).Materials And MethodsRandomized, multicenter, double-blind, placebo-controlled, phase 1b/2a trial. Patients with severe CABP were enrolled to receive intravenous infusions of Cx611 or placebo. The primary objective was safety including hypersensitivity reactions, thromboembolic events, and immunological responses to Cx611. The secondary endpoints included the clinical cure rate, ventilation-free days, and overall survival (Day 90).ResultsEighty-three patients were randomized and received infusions (Cx611: n = 42]; placebo: n = 41]. The mean age was similar (Cx611: 61.1 [11.2] years; placebo: 63.4 [10.4] years). The number of AEs and treatment-emergent AEs were similar (243; 184 and 2; 1) in Cx611 and placebo respectively. Hypersensitivity reactions or thromboembolic events were similar (Cx611: n = 9; placebo: n = 12). Each study arm had similar anti-HLA antibody/DSA levels at Day 90. The clinical cure rate (Cx611: 86.7%; placebo: 93.8%), mean number of ventilator-free days (Cx611: 12.2 [10.29] days; placebo: 15.4 [10.75] days), and overall survival (Cx611: 71.5%; placebo: 77.0%) did not differ between study arms.ConclusionCx611 was well tolerated in severe CABP. These data provide insights for future stem cell clinical study designs, endpoints and sample size calculation.Trial RegistrationNCT03158727 (retrospectively registered: May 09, 2017). Full study protocol: https://clinicaltrials.gov/ProvidedDocs/27/NCT03158727/Prot_000.pdf.Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.

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