Table 4.

CRATUS Phase 1: Changes From Baseline in Secondary Efficacy Parameters

	Allo-20M (N = 5)	Allo-100M (N = 5)	Allo-200M (N = 5)
6MWD
3 mo, mean (95% CI)	27.6 m (−5.5, 60.7), p = .09	36.6 m (3.5, 69.7), p = .03	3.6 m (−29.5, 36.7), p = .82
6 mo, mean (95% CI)	37.2 m (1.4, 73.0), p = .04	76.6 m (40.8, 112.4), p = .0005	4.2 m (−31.6, 40.0), p = .80
FEV1
3 mo, mean (95% CI)	−0.07 L (−0.28, 0.14), p = .51	0.17 L (−0.04, 0.38), p = .10	0.26 L (0.05, 0.47), p = .02
6 mo, mean (95% CI)	−0.01 L (−0.27, 0.25), p = .93	0.04 L (−0.22, 0.30), p = .76	0.23 L (−0.03, 0.49), p = .08
MMSE
6 mo, median (IQR)	0.5 (3.0), p = .75	2.0 (1.0), p = .13	0.0 (0.0), p = 1.00
TNF-α
6 mo, mean (95% CI)	−1.2 (−2.7, 0.2), p = .09	−3.7 (−5.1, −2.2), p = .0001	−3.8 (−5.2, −2.3), p = .0001
EQ-5D
1 mo, median (IQR)	−1.0 (1.0), p = .75	−1.0 (2.0), p = .25	−1.0 (0.0), p = .56
3 mo, median (IQR)	1.0 (3.0), p = .69	−1.0 (0.0), p = .13	−1.0 (2.0), p = .88
6 mo, median (IQR)	1.0 (2.0), p = 1.00	−1.0 (1.0), p = .13	−1.0 (0.0), p = .56
SF-36 Physical Component Score
1 mo, mean (95% CI)	0.06 (−5.72, 5.84), p = .98	10.48 (4.70, 16.26), p = .002	0.36 (−5.41, 6.14), p = .89
3 mo, mean (95% CI)	−0.87 (−7.01, 5.27), p = .76	6.92 (0.78, 13.06), p = .03	0.04 (−6.10, 6.18), p = .99
6 mo, mean (95% CI)	2.49 (−4.73, 9.70), p = .47	7.80 (0.59, 15.02), p = .04	−0.10 (−7.32, 7.12), p = .98
SF-36 Mental Component Score
1 mo, mean (95% CI)	3.28 (−3.49, 10.04), p = .31	0.83 (−5.93, 7.59), p = .79	1.07 (−5.69, 7.84), p = .74
3 mo, mean (95% CI)	−5.68 (−13.69, 2.33), p = .15	1.13 (−6.88, 9.14), p = .76	−0.15 (−8.16, 7.86), p = .97
6 mo, mean (95% CI)	−8.07 (−16.79, 0.65), p = .07	1.13 (−7.59, 9.84), p = .78	5.99 (−2.73, 14.71), p = .16

Note: CI = confidence interval; FEV1 = forced expiratory volume in 1 second; IQR = interquartile range; MMSE = Mini-Mental State Examination; 6MWD = 6-minute walk distance; TNF = tumor necrosis factor.