At a glance
ClinicalIndex Comparison Record- ✓Adult aged 18–80 years
- ✓Body weight 50–100 kg
- ✓Clinical diagnosis of acute community-acquired bacterial pneumonia developed within ≤21 days with two relevant signs (fever, tachypnoea, leukocytosis, or hypoxemia) and radiographic evidence of new pulmonary infiltrate(s)
- ✓Pneumonia of sufficient severity requiring ICU management with at least one major severity criterion (invasive mechanical ventilation OR vasopressors for shock) present for <18 hours
- ✕Hospital-acquired (HAP), healthcare-acquired (HCAP), or ventilator-associated pneumonia (VAP)
- ✕Pneumonia exclusively of viral or fungal origin
- ✕Suspected or confirmed Pneumocystis jirovecii pneumonia
- ✕Aspiration pneumonia
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase Ib/IIa, Randomised, Double Blind, Parallel Group, Placebo Controlled, Multicentre Study to Assess the Safety and Efficacy of Expanded Cx611 Allogeneic Adipose-derived Stem Cells (eASCs) for the Intravenous Treatment of Adult Patients With Severe Community-acquired Bacterial Pneumonia and Admitted to the Intensive Care Unit
In Brief
A Phase 2 clinical trial evaluating Cx611 and Placebo for Bacterial Pneumonia. Completed, enrolled 84 participants across 33 sites in 6 countries.
Detailed 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.
Study Details
Timeline
Interventions
Two intravenous infusions, one on day 1 and another one on day 3.
Two intravenous infusions, one on day 1 and another one on day 3.