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Table 4 Longitudinal change of MRI and clinical outcomes for case and control groups over the 1-year follow-up

From: Cartilage regeneration and inflammation modulation in knee osteoarthritis following injection of allogeneic adipose-derived mesenchymal stromal cells: a phase II, triple-blinded, placebo controlled, randomized trial

Measurement

Group

Baseline

3 months

6 months

12 months

P value

WOMAC

AD-MSCs

58.35 ± 13.25

25.90 ± 14.57

16.75 ± 13.81

19.05 ± 14.12

 < 0.001

 

Control

65.42 ± 14.63

54.73 ± 17.07

55.63 ± 23.17

63.47 ± 20.68

 

VAS

AD-MSCs

7.40 ± 1.35

3.75 ± 1.58

3.15 ± 1.87

3.25 ± 1.58

 < 0.001

 

Control

7.73 ± 1.14

6.10 ± 1.48

7 ± 1.85

7.47 ± 1.54

 

KOOS

      

Pain

AD-MSCs

35.40 ± 15.30

69.80 ± 12.52

79.45 ± 11.97

73.25 ± 16.11

 < 0.001

Control

25.10 ± 14.12

38.78 ± 16.12

32.10 ± 21.02

27 ± 20.72

Symptom

AD-MSCs

50.45 ± 23.65

79.95 ± 20.52

89.15 ± 15.16

84.35 ± 15.76

 < 0.001

Control

42.15 ± 23.53

57.89 ± 20.40

53.05 ± 20.09

41.68 ± 20.49

Quality of life

AD-MSCs

16.90 ± 16.94

56.90 ± 18.31

64.60 ± 17.58

60.35 ± 18.94

 < 0.001

Control

13.26 ± 11.47

27.05 ± 15.34

18.78 ± 18.24

16.78 ± 18.33

Daily function

AD-MSCs

32.80 ± 15.26

68.70 ± 15.16

80.85 ± 13.64

78.10 ± 15.80

 < 0.001

Control

30.52 ± 14.43

42.15 ± 17.87

39.78 ± 22.61

32.89 ± 20.80

Sport & recreation

AD-MSCs

3.46 ± 16.18

28 ± 20.35

33.50 ± 23.95

21.75 ± 18.58

 < 0.001

Control

6.75 ± 22.37

5 ± 6.45

1.84 ± 5.05

1.05 ± 3.15

Total KOOS

AD-MSCs

28.30 ± 14.90

60.60 ± 10.20

69.15 ± 12.22

63.75 ± 15.40

 < 0.001

Control

22.05 ± 9.57

34.68 ± 13.50

29.57 ± 16.28

23.84 ± 15.09

SF-36

PF

AD-MSCs

29.50 ± 11.90

61.75 ± 17.03

72.75 ± 16.66

72.50 ± 17.65

 < 0.001

Control

29.47 ± 11.04

38.42 ± 17.79

32.10 ± 17.58

28.68 ± 14.79

RP

AD-MSCs

25 ± 18.13

85 ± 27.38

88.75 ± 17.15

96.25 ± 12.23

 < 0.001

Control

26.31 ± 21.20

53.94 ± 31.47

36.84 ± 25.50

31.57 ± 32.10

BP

AD-MSCs

15.12 ± 15.68

58.87 ± 20

66.50 ± 20.98

65.25 ± 15.89

 < 0.001

Control

15.13 ± 14.58

36.31 ± 22.25

21.44 ± 17.85

23.02 ± 24.44

GH

AD-MSCs

37 ± 13.70

70.25 ± 17.73

72.50 ± 14.18

71.75 ± 18.01

 < 0.001

Control

31.84 ± 12.15

47.89 ± 17.89

32.05 ± 19.69

26.57 ± 19.72

VT

AD-MSCs

56.25 ± 12.01

68 ± 15.42

69.75 ± 11.52

71 ± 11.42

 < 0.001

Control

46.31 ± 15.44

58.94 ± 13.49

48.68 ± 14.79

46.05 ± 20.58

SF

AD-MSCs

30 ± 24.12

64.37 ± 17.33

72 ± 21.36

69.37 ± 16.46

 < 0.001

Control

32.23 ± 22.17

51.57 ± 23.69

37.50 ± 20.83

24.34 ± 23

RE

AD-MSCs

9.99 ± 19.02

81.66 ± 29.57

86.66 ± 25.13

95 ± 16.31

 < 0.001

Control

14.02 ± 20.22

54.37 ± 37.02

24.55 ± 34.85

19.30 ± 35.69

MH

AD-MSCs

22.50 ± 19.70

70 ± 15.38

81.25 ± 19.65

85 ± 17.01

 < 0.001

Control

15.78 ± 19.02

48.68 ± 26.96

36.84 ± 26.83

25 ± 26.35

MRI (mm)

TMA

AD-MSCs

1.86 ± 0.53

–

–

1.98 ± 0.56

 < 0.05

Control

1.49 ± 0.88

–

–

1.37 ± 0.81

TMC

AD-MSCs

1.78 ± 0.69

–

–

1.79 ± 0.69

0.840

Control

1.76 ± 0.7

–

–

1.71 ± 0.68

TMP

AD-MSCs

2.01 ± 0.29

–

–

2.07 ± 0.26

 < 0.01

Control

1.81 ± 0.25

–

–

1.78 ± 0.18

TLA

AD-MSCs

1.70 ± 0.75

–

–

1.67 ± 0.71

0.997

Control

1.70 ± 0.66

–

–

1.67 ± 0.65

TLC

AD-MSCs

2.01 ± 0.42

–

–

2.05 ± 0.41

0.420

Control

1.90 ± 0.61

–

–

1.88 ± 0.58

 

TLP

AD-MSCs

1.77 ± 0.31

–

–

1.82 ± 0.26

0.414

Control

1.98 ± 0.52

–

–

1.82 ± 0.46

FMA

AD-MSCs

2.20 ± 0.67

–

–

2.22 ± 0.63

0.397

Control

1.99 ± 1.01

–

–

1.94 ± 0.98

FMC

AD-MSCs

1.78 ± 0.82

–

–

1.81 ± 0.83

0.462

Control

1.59 ± 0.9

–

–

1.57 ± 0.87

FMP

AD-MSCs

2.36 ± 0.79

–

–

2.39 ± 0.76

0.823

Control

2.43 ± 0.72

–

–

2.43 ± 0.73

FLA

AD-MSCs

1.97 ± 0.65

–

–

2.15 ± 0.67

0.677

Control

2.19 ± 0.45

–

–

2.09 ± 0.48

FLC

AD-MSCs

1.81 ± 0.43

–

–

1.80 ± 0.39

0.731

Control

1.86 ± 0.43

–

–

1.84 ± 0.42

FLP

AD-MSCs

2.20 ± 0.61

–

–

2.23 ± 0.72

0.611

Control

2.38 ± 0.63

–

–

2.28 ± 0.60

  1. Values are given as mean ± standard deviations of the mean
  2. AD-MSCs Adipose-derived mesenchymal stromal cells, SF-36 36-Item Short Form Survey, PF physical functioning, RP role physical, BP body pain, GH general health, VT vitality, SF social functioning, RE role emotional, MH mental health, KOOS Knee injury and Osteoarthritis Outcome Score, WOMAC Western Ontario and McMaster Universities Osteoarthritis index, VAS visual analog scale, MRI magnetic resonance imaging, FLA femur lateral anterior, FMC femur medial central, FMP femur medial posterior, FMA femur medial anterior, TLA tibia lateral anterior, TLC tibia lateral central, TLP tibia lateral posterior, TMA tibia medial anterior, TMC tibia medial central, TMP tibia medial posterior