Clinical efficacy and safety of multipotent adult progenitor cells (invimestrocel) for acute respiratory distress syndrome (ARDS) caused by pneumonia: a randomized, open-label, standard therapy–controlled, phase 2 multicenter study (ONE-BRIDGE)

Table 2 Ventilator-free days, ventilator weaning, re-intubation rate, and mortality rate (modified intent-to-treat analysis set)

	Invimestrocel group (N = 20)	Standard group (N = 10)	p value
Primary outcome
VFD from day 0 to day 28, days
Mean (SD)	14.8 (11.0)	10.6 (10.0)
Median (IQR)	20.0 (0.0–24.0)	11.0 (0.0–14.0)
LS mean^a (95% CI)	11.6 (6.9–16.3)	6.2 (–0.4 to 12.8)
LS mean difference (95% CI)	5.4 (–1.9 to 12.8)		0.1397^b
Secondary outcomes
Ventilator weaning at day 28
n (%)	13 (65)	3 (30)	−
Missing, n	5	5
Number of patients with ventilation weaning at least once	15	9
Re-intubation	4/15 (27)	3/9 (33)	−
Ventilation weaning after re-intubation	4/15 (27)	1/9 (11)	−
Mortality
Day 28
n/non-missing (%)	4/19 (21)	2/7 (29)	1.000^c
Missing, n	1	3
Day 60
n/non-missing (%)	5/19 (26)	3/7 (43)	0.6353^c
Missing, n	1	3
Day 90
n/non-missing (%)	5/19 (26)	3/7 (43)	0.6353^c
Missing, n	1	3
Day 180^d
n/non-missing (%)	5/19 (26)	3/7 (43)	0.6353^c
Missing, n	1	3

Percentages are calculated using the N as the denominator except where indicated (invimestrocel group, N = 20; standard group, N = 10)
APACHE II Acute Physiology and Chronic Health Evaluation II, IQR interquartile range, LS least squares, PaO₂/F_IO₂ partial pressure arterial oxygen/fraction of inspired oxygen, VFD ventilator-free days
^aAnalysis of covariance using treatment group, age at enrollment (< 75 years, ≥ 75 years), PaO₂/F_IO₂ ratio (> 100 mmHg, ≤ 100 mmHg), and APACHE II score as covariates
^bWilcoxon rank sum test
^cFisher’s exact test
^dThose who completed the study before day 180 were considered alive

ISSN: 1757-6512