Skip to main content

Table 1 Summary of demographic data—ITT population at the screening visit

From: Treatment of knee osteoarthritis with intra-articular injection of allogeneic adipose-derived stem cells (ADSCs) ELIXCYTE®: a phase I/II, randomized, active-control, single-blind, multiple-center clinical trial

Demographic data ITT population
HA 16 M 32 M 64 M Total
N (Missing) 8 (0) 17 (0) 17 (0) 15 (0) 57 (0)
Age (year)      
Mean (SD) 70.5 (8.37) 67.7 (6.84) 68.6 (6.45) 64.9 (4.91) 67.6 (6.60)
Median (IQR) 73.5 (13.0) 66.0 (5.0) 68.0 (9.0) 65.0 (8.0) 67.0 (10.0)
Q1 ~ Q3 64.0 ~ 77.0 65.0 ~ 70.0 65.0 ~ 74.0 60.0 ~ 68.0 63.0 ~ 73.0
Min ~ Max 56.0 ~ 79.0 51.0 ~ 78.0 55.0 ~ 78.0 59.0 ~ 75.0 51.0 ~ 79.0
p-value (T test) 0.3835 0.5356 0.0531
Gender      
Male 3 (37.5%) 3 (17.6%) 2 (11.8%) 3 (20.0%) 11 (19.3%)
Female 5 (62.5%) 14 (82.4%) 15 (88.2%) 12 (80.0%) 46 (80.7%)
p-value (FISHER) 0.3442 0.2833 0.6214
Body height (cm)      
Mean (SD) 154.0 (12.42) 154.7 (7.51) 155.0 (6.75) 156.5 (7.36) 155.2 (7.92)
Median (IQR) 148.8 (23.9) 155.0 (7.5) 153.5 (6.9) 155.4 (8.5) 154.2 (9.1)
Q1 ~ Q3 143.8 ~ 167.7 149.5 ~ 157.0 151.0 ~ 157.9 152.0 ~ 160.5 149.5 ~ 158.6
Min ~ Max 141.0 ~ 170.3 142.0 ~ 177.2 147.7 ~ 176.0 145.3 ~ 168.3 141.0 ~ 177.2
p-value (Wilcox_t) 0.5275 0.3907 0.4656
Body weight (Kg)      
Mean (SD) 60.5 (10.80) 66.0 (6.80) 64.2 (10.97) 62.9 (10.47) 63.9 (9.64)
Median (IQR) 64.3 (18.5) 65.0 (6.9) 63.2 (13.1) 63.8 (16.6) 63.8 (12.9)
Q1 ~ Q3 49.4 ~ 67.8 62.0 ~ 68.9 56.4 ~ 69.5 55.7 ~ 72.3 56.6 ~ 69.5
Min ~ Max 46.2 ~ 74.6 55.6 ~ 77.4 48.0 ~ 87.2 42.3 ~ 80.2 42.3 ~ 87.2
p-value (T test) 0.1321 0.4293 0.6015
BMI (Kg/m2)      
Mean (SD) 25.47 (3.494) 27.65 (3.026) 26.72 (4.192) 25.66 (3.782) 26.54 (3.673)
Median (IQR) 24.64 (3.89) 28.28 (4.68) 25.98 (3.68) 25.67 (5.78) 25.98 (5.22)
Q1 ~ Q3 23.33 ~ 27.21 25.03 ~ 29.70 24.56 ~ 28.24 22.90 ~ 28.68 23.83 ~ 29.05
Min ~ Max 21.09 ~ 32.29 23.14 ~ 32.26 20.37 ~ 34.59 19.39 ~ 31.33 19.39 ~ 34.59
p-value (T test) 0.1232 0.4724 0.9088
Kellgren–Lawrence grade on target knee      
Grade II 5 (62.5%) 10 (58.8%) 10 (58.8%) 12 (80.0%) 37 (64.9%)
Grade III 3 (37.5%) 7 (41.2%) 7 (41.2%) 3 (20.0%) 20 (35.1%)
p-value (FISHER) 1.0000 1.0000 0.6214
Disease duration (years)      
Mean (SD) 2.44 (2.367) 2.97 (1.755) 3.68 (7.198) 2.39 (1.634) 2.96 (4.164)
Median (IQR) 2.05 (2.24) 2.97 (2.13) 2.04 (2.48) 2.08 (2.48) 2.26 (2.24)
Q1 ~ Q3 0.81 ~ 3.05 2.06 ~ 4.20 0.20 ~ 2.68 1.12 ~ 3.59 1.12 ~ 3.36
Min ~ Max 0.10 ~ 7.58 0.00 ~ 5.87 0.00 ~ 29.68 0.16 ~ 5.86 0.00 ~ 29.68
p-value (Wilcox_t) 0.3755 0.7514 0.8733
  1. For CI and p-value (between groups), FISHER denotes Fisher's exact test, T denotes two-sample t-test, Wilcox_t denotes Wilcoxon rank-sum test (Mann–Whitney U Test) in t approximation