Effect of mesenchymal stromal cell infusions on lung function in COPD patients with high CRP levels

Respiratory Research

Table 2 Day 120 efficacy analysis by baseline CRP subgroups (sensitivity analysis)

	Placebo	MSC	Difference	P-value^a
Subgroup/parameter
Baseline CRP ≥ 4 mg/L	N = 17	N = 12
Mean change from baseline:
FEV₁ (L)	− 0.094	0.063	0.156	0.003
FVC (L)	− 0.249	0.111	0.360	0.009
6MWD (m)	− 3.118	52.167	55.284	0.004
Baseline CRP < 4 mg/L	N = 15	N = 18
Mean change from baseline:
FEV₁ (L)	− 0.009	− 0.083	− 0.074	0.123
FVC (L)	− 0.051	− 0.122	− 0.071	0.461
6MWD (m)	38.933	10.333	− 28.600	0.116
Baseline CRP ≥ 3 mg/L	N = 21	N = 14
Mean change from baseline:
FEV₁ (L)	− 0.074	0.051	0.125	0.009
FVC (L)	− 0.217	0.109	0.326	0.006
6MWD (m)	5.952	42.571	36.619	0.040
Baseline CRP < 3 mg/L	N = 11	N = 16
Mean change from baseline:
FEV₁ (L)	− 0.015	− 0.091	− 0.076	0.165
FVC (L)	− 0.041	− 0.149	− 0.109	0.333
6MWD (m)	36.909	13.500	− 23.409	0.270
Baseline CRP ≥ 2 mg/L	N = 23	N = 19
Mean change from baseline:
FEV₁ (L)	− 0.073	0.009	0.083	0.055
FVC (L)	− 0.199	0.042	0.241	0.022
6MWD (m)	8.391	31.632	23.241	0.159
Baseline CRP < 2 mg/L	N = 9	N = 11
Mean change from baseline:
FEV₁ (L)	− 0.004	− 0.084	− 0.079	0.235
FVC (L)	− 0.047	− 0.150	− 0.103	0.435
6MWD (m)	37.556	19.182	− 18.374	0.444

CRP C-reactive protein, FEV₁ forced expiratory volume—one second, FVC forced vital capacity, 6MWD 6-min walk distance
^aP-value for difference between placebo and remestemcel-L groups by Student t-test for independent groups

ISSN: 1465-993X