Table 1 Clinical and demographic features

From: Dose-escalation studies of mesenchymal stromal cell therapy for decompensated liver cirrhosis: phase Ia/Ib results and immune modulation insights

 

Phase Ia

Phase Ib

Total (n = 24)

Cohort I (n = 3)

Cohort II (n = 3)

Cohort III (n = 6)

Cohort IV (n = 3)

Cohort A (n = 3)

Cohort B (n = 6)

Age (years)

46.00 ± 11.14

49.33 ± 8.62

60.17 ± 6.65

42.00 ± 12.53

56.33 ± 12.06

47.00 ± 4.69

51.00 ± 10.10

Sex, n (%)

 male

3 (100.00)

2 (66.67)

1 (16.67)

2 (66.67)

3 (100.00)

4 (66.67)

15 (62.50)

 female

0 (0.00)

1 (33.33)

5 (83.33)

1 (33.33)

0 (0.00)

2 (33.33)

9 (37.50)

 BMI(kg/m2)

24.86 ± 1.97

24.89 ± 1.72

20.45 ± 2.83

24.00 ± 2.92

24.55 ± 1.98

25.58 ± 5.72

23.79 ± 3.83

Pathogenesis, n (%)

 Hepatitis B

2 (66.67)

1 (33.33)

1 (16.67)

3 (100.00)

0 (0.00)

2 (33.33)

9 (37.50)

 Hepatitis C

0 (0.00)

0 (0.00)

1 (16.67)

0 (0.00)

0 (0.00)

0 (0.00)

1 (4.17)

 Alcohol

1 (33.33)

1 (33.33)

1 (16.67)

0 (0.00)

3 (100.00)

3 (50.00)

9 (37.50)

 Primary biliary cirrhosis

0 (0.00)

1 (33.33)

3 (50.00)

0 (0.00)

0 (0.00)

1 (16.67)

5 (20.83)

 MELD Score

12.67 ± 3.21

16.67 ± 1.15

11.67 ± 4.27

12.33 ± 3.51

12.00 ± 3.46

11.00 ± 2.68

12.38 ± 3.42

 Child–Pugh Score

7.33 ± 0.58

9.00 ± 2.00

8.50 ± 1.87

7.67 ± 1.15

8.33 ± 1.15

7.83 ± 0.98

8.12 ± 1.36

 EQ-5D VAS

76.67 ± 15.28

89.67 ± 8.08

74.17 ± 18.00

65.00 ± 13.23

69.67 ± 9.50

74.17 ± 10.21

74.71 ± 13.70

 CLQD, M (Q₁, Q₃)

181.00 (166.00,183.50)

201.00 (195.50,202.00)

177.50 (167.50,182.25)

116.00 (110.50,132.00)

158.00 (128.50,166.00)

132.50 (104.75,144.50)

154.50 (120.50, 181.50)

Comorbidities, n (%)

 Gastrointestinal diseases

1 (33.33)

1 (33.33)

3 (50.00)

1 (33.33)

3 (100.00)

6 (100.00)

15 (62.50)

 Diabetes

0 (0.00)

0 (0.00)

0 (0.00)

1 (33.33)

2 (66.67)

1 (16.67)

4 (16.67)

 Hypertension

0 (0.00)

0 (0.00)

1 (16.67)

0 (0.00)

0 (0.00)

0 (0.00)

1 (4.17)

Complications of liver cirrhosis, n (%)

 Ascites

3 (100.00)

2 (66.67)

5 (83.33)

3 (100.00)

3 (100.00)

3 (50.00)

19 (79.17)

 Esophageal and gastric varices

2 (66.67)

3 (100.00)

5 (83.33)

1 (33.33)

3 (100.00)

5 (83.33)

19 (79.17)

 Hepatic encephalopathy

0 (0.00)

0 (0.00)

2 (33.33)

1 (33.33)

1 (33.33)

3 (50.00)

7 (29.17)

laboratory data

 WBC, (109/L)

1.95 ± 0.83

2.53 ± 1.04

2.72 ± 1.03

3.23 ± 0.73

3.47 ± 1.89

3.32 ± 1.27

2.91 ± 1.16

 Hemoglobin, (g/L)

122.33 ± 26.50

97.00 ± 13.00

104.17 ± 16.46

113.33 ± 24.66

92.67 ± 21.36

105.33 ± 16.79

105.54 ± 19.10

 Prothrombin time activity,(%)

62.97 ± 23.59

43.57 ± 6.46

72.52 ± 32.10

66.17 ± 16.55

64.40 ± 18.89

65.18 ± 9.32

64.06 ± 20.60

 Total bilirubin,(umol/L)

35.07 ± 18.75

52.80 ± 13.76

39.87 ± 19.43

39.80 ± 23.76

32.23 ± 10.75

35.22 ± 31.34

38.76 ± 20.94

 Albumin,(g/L)

41.67 ± 11.59

31.67 ± 6.11

32.17 ± 4.45

32.67 ± 5.03

33.67 ± 4.73

30.17 ± 5.64

33.04 ± 6.53

 Prealbumin,(mg/L)

85.58 ± 37.93

104.67 ± 16.26

58.33 ± 25.17

73.17 ± 30.52

107.00 ± 64.37

118.33 ± 50.52

75.00 ± 27.31

 Cholinesterase,(U/L)

3333.00 ± 762.04

1524.00 ± 340.99

2937.50 ± 1391.54

4757.00 ± 3896.82

3599.33 ± 1836.31

2800.83 ± 715.59

3086.25 ± 1719.97

  1. BMI Weight(kg)/Height(m)2
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