The safety and efficacy of stem cells for the treatment of severe community-acquired bacterial pneumonia: A randomized clinical trial
Authors' conclusion
Cx611 was well tolerated in severe CABP.
Study context
- Population
- Patients with severe community-acquired bacterial pneumoniarandomised and infused
- Participants
- 83 patients
- Comparison
- IV Cx611 vs placebo
- Cx611n = 42
- Placebon = 41reference
- Primary endpoint
- Safety, including hypersensitivity reactions, thromboembolic events and immunological responses to Cx611
Methodological detailsmulticentre, double-blind, placebo-controlled, phase 1b/2a, Retrospectively registered
- Multicentre
- Double-blind
- Placebo-controlled
- Phase 1b/2a
- Retrospectively registered
Primary result
As reported in the abstract
Safety
| Group | AEs | Treatment-emergent AEs | Hypersensitivity reactions or thromboembolic events |
|---|---|---|---|
| Cx611 | 243 | 2 | 9 |
| Placebo | 184 | 1 | 12 |
AEs
Cx611243
Placebo184
Treatment-emergent AEs
Cx6112
Placebo1
Hypersensitivity reactions or thromboembolic events
Cx6119
Placebo12
Secondary outcomes
Clinical cure rate
Overall survival · Day 90
Ventilator-free days
Clinical cure rate
- Did not differ between study arms
Ventilator-free days
- Did not differ between study arms
Overall survival · Day 90
- Did not differ between study arms
Safety
| Outcome | Cx611 | Placebo |
|---|---|---|
| AEs, treatment-emergent AEs, hypersensitivity reactions or thromboembolic events | ||
| AEs | 243 | 184 |
| Treatment-emergent AEs | 2 | 1 |
| Hypersensitivity reactions or thromboembolic events | 9 | 12 |
AEs, treatment-emergent AEs, hypersensitivity reactions or thromboembolic events
- Similar between arms
Original publication
The safety and efficacy of stem cells for the treatment of severe community-acquired bacterial pneumonia: A randomized clinical trial. J Crit Care. Published 31 October 2023. doi:10.
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