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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