Regenerative therapy · 2025
Clinical efficacy of invimestrocel for acute respiratory distress syndrome caused by pneumonia: Comparison with historical data using propensity score analysis.
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Ichikado Kazuya, Kotani Toru, Kawamura Kodai, Kondoh Yasuhiro, Imanaka Hideaki, Johkoh Takeshi, Fujimoto Kiminori, Nunomiya Shin, Kawayama Tomotaka, Sawada Masanori, Tasaka Sadatomo, Ichiyasu Hidenori, Sakagami Takuro, Hashimoto Satoru
Аннотация
INTRODUCTION: Acute respiratory distress syndrome (ARDS) is a life-threatening inflammatory lung injury often resulting from pneumonia. The efficacy and safety of invimestrocel in patients with pneumonia-induced ARDS have been demonstrated previously in a phase II randomized, open-label trial (the ONE-BRIDGE study). In this study, we aimed to compare data from the intervention (invimestrocel) arm of the ONE-BRIDGE study with matched historical data from a previously established cohort to provide further support for the beneficial effects of invimestrocel in patients with pneumonia-induced ARDS.
METHODS: Twenty patients from the invimestrocel arm of the ONE-BRIDGE study (Invimestrocel group) and 104 from the historical cohort were included in this study. A matched historical data group (n = 20) was extracted from the historical cohort based on the propensity score analysis using age, sex, PaO2/FIO2 ratio, and high-resolution computed tomography scores. The primary outcomes measured were ventilator-free days (VFDs) during the first 28 days following treatment and mortality on days 28, 60, 90, and 180.
RESULTS: Patients in the Invimestrocel group showed higher VFDs (14.8 ± 11.0 vs. 6.7 ± 9.4 days; 95 % confidence interval [CI], 1.4-14.7; p = 0.0110) and survival rates (log-rank testing; hazard ratio, 0.330; 95 % CI, 0.116-0.938) than those in the matched historical data group.
CONCLUSIONS: The addition of invimestrocel to the standard treatment for pneumonia-induced ARDS may result in early withdrawal from the ventilator and lower mortality. However, further randomized, blinded, and placebo-controlled studies without or addressing multiplicity are required to confirm these findings.
METHODS: Twenty patients from the invimestrocel arm of the ONE-BRIDGE study (Invimestrocel group) and 104 from the historical cohort were included in this study. A matched historical data group (n = 20) was extracted from the historical cohort based on the propensity score analysis using age, sex, PaO2/FIO2 ratio, and high-resolution computed tomography scores. The primary outcomes measured were ventilator-free days (VFDs) during the first 28 days following treatment and mortality on days 28, 60, 90, and 180.
RESULTS: Patients in the Invimestrocel group showed higher VFDs (14.8 ± 11.0 vs. 6.7 ± 9.4 days; 95 % confidence interval [CI], 1.4-14.7; p = 0.0110) and survival rates (log-rank testing; hazard ratio, 0.330; 95 % CI, 0.116-0.938) than those in the matched historical data group.
CONCLUSIONS: The addition of invimestrocel to the standard treatment for pneumonia-induced ARDS may result in early withdrawal from the ventilator and lower mortality. However, further randomized, blinded, and placebo-controlled studies without or addressing multiplicity are required to confirm these findings.