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Table 1 Comparative analysis of multi-domain outcomes at 6- and 12-month post-hospital discharge: UC-MSCs versus placebo

From: Treatment of COVID-19-associated ARDS with umbilical cord-derived mesenchymal stromal cells in the STROMA-CoV-2 multicenter randomized double-blind trial: long-term safety, respiratory function, and quality of life

 

6 months

12 months

UC-MSCs (n = 21)

Placebo (n = 24)

All cohort (n = 45)

P**

UC-MSCs (n = 21)

Placebo (n = 24)

All cohort (n = 45)

P**

Number of patients with adverse events [n (%)]

18 (85.7)

20 (83.3)

38 (84.4)

1.0

19 (90.5)

20 (83.3)

39 (86.7)

0.67

Number of patients with serious adverse events [n (%)]

9 (42.9)

9 (37.5)

18 (40.0)

0.77

9 (42.9)

9 (37.5)

18 (40)

0.77

Mortality [n (%)]

7 (38.9)

Loss-to-follow-up

N = 3

5 (27.8)

Loss-to-follow-up

N = 6

12 (33.3)

Loss-to-follow-up

N = 9

0.72

7 (50)

Loss-to-follow-up

N = 7

5 (29.4)

Loss-to-follow-up

N = 7

12 (38.7)

Loss-to-follow-up

N = 14

0.29

HRCT

N = 11

N = 13

N = 24

 

N = 7

N = 12

N = 19

 

Lung nodules present [n (%)]

4 (36.4)

1 (7.7)

5 (20.8)

0.14

4 (57.1)

4 (33.3)

8 (42.1)

0.38

Groundglass present [n (%)]

7 (63.6)

4 (30.8)

11 (45.8)

0.22

3 (42.9)

2 (16.7)

5 (26.3)

0.30

Reticular opacities present [n (%)]

0 (0)

0 (0)

0 (0)

NA

0 (0)

1 (8.3)

1 (5.3)

1.0

Lung fibrosis present [n (%)]

1 (9.1)

2 (15.4)

3 (12.5)

1.0

0(0)

0 (0)

0 (0)

NA

Pleural effusion present [n (%)]

0 (0)

1 (7.7)

1 (4.2)

1.0

0(0)

0 (0)

0(0)

NA

Bronchi(ol)ectasis present [n (%)]

3 (27.3)

0 (0)

3 (12.5)

0.08

0 (0)

2 (16.7)

2 (10.5)

0.51

Pulmonary function test

N = 11

N = 13*

N = 24

 

N = 6

N = 6

N = 12

 

TLC (L)

5.4 (1.3)

5.6 (1.3)

5.5 (1.3)

0.84

5.5 (1.5)

5.9 (0.7)

5.7 (1.1)

0.82

TLC (% of predicted)

85.8 (18.2)

91.9 (16.2)

89.1 (17.1)

0.35

89 (19)

85.7 (9.6)

87.3 (14.5)

0.94

RV (L)

2.6 (0.7)

2.86 (0.9)

2.7 (0.8)

0.62

2.5 (0.7)

2.9 (0.7)

2.7 (0.7)

0.59

RV (% of predicted)

78.1 (18.9)

89.6 (26.1)

84.3 (23.4)

0.26

78.8 (22.3)

79.5 (15.2)

79.2 (18.2)

0.81

FEV1 (L)

2.9 (0.8)

3.0 (0.6)

2.9 (0.6)

0.66

2.9 (0.9)

3.1 (0.7)

3.0 (0.8)

0.70

FEV1 (% of predicted)

96.6 (14.5)

100.9 (21.5)

98.9 (18.0)

0.43

99 (11.9)

96.7 (25.2)

97.8 (18.8)

0.70

FEV1/FVC (ratio)

83 (5)

78 (8)

80.0 (7)

0.07

80.7 (5.1)

77.8 (8.8)

79.2 (7)

0.52

FEV1/SVC (ratio)

81 (6)

77 (8)

79 (7)

0.34

80.3 (6.7)

73.5 (8)

76.9 (7.9)

0.11

SNIP (cmH2O)

82.2 (23.6)

70.2 (27)

75.6 (25.6)

0.30

84.3 (23.6)

84.2 (35.3)

84.3 (27.9)

1.00

SNIP (% of predicted)

87 (18.8)

73.1 (24.5)

79.3 (22.7)

0.21

92 (29.7)

84.2 (33.9)

88.5 (30.3)

0.78

MEP (cmH2O)

144.1 (56.8)

134.5 (53.9)

138.8 (54)

0.52

127.2 (43.9)

147.2 (66.4)

136.3 (53.2)

0.66

MEP (% of predicted)

76.9 (27.4)

77.1 (39.4)

77 (33.7)

0.50

70.7 (25.2)

89.6 (67)

79.3 (47)

1.00

MIP (cmH2O)

111.3 (36.9)

86.4 (29.9)

97.6 (34.7)

0.04

120.6 (30.3)

86.6 (30.3)

102.5 (17.1)

0.07

MIP (% of predicted)

114 (45.2)

91.5 (37.6)

101.7 (41.6)

0.24

131 (49.3)

76.6 (21.2)

103.8 (45.8)

0.10

DLCO (% of predicted)

71.2 (9.5)

70.8 (24.8)

71.0 (19.3)

0.66

67.5 (6.5)

67.3 (12.2)

67.4 (9.4)

0.69

Blood gas

N = 11

N = 11

N = 22

 

N = 5

N = 7

N = 12

 

pH

7.44 (0.06)

7.4 (0.04)

7.42 (0.05)

0.05

7.43 (0.03)

7.41 (0.01)

7.42 (0.02)

0.19

PaO2 (mmHg)

88.9 (9.3)

93.6 (10.4)

91.2 (9.9)

0.14

94 (13.7)

89.29 (11.7)

91.3 (12.2)

0.63

PaCO2 (mmHg)

37.6 (6.4)

38 (3.46)

37.8 (5.0)

0.77

37 (3.7)

38.9 (4.5)

38.1 (4.1)

0.46

SaO2 (%)

97.27 (1.2)

97.64 (1.6)

97.5 (1.4)

0.17

97.6 (1.1)

97.1 (1.9)

97.3 (1.6)

0.86

HCO3− (mmol/L)

25.36 (2.3)

23.45 (2.2)

24.4 (2.4)

0.10

24.8 (0.9)

24.3 (1.9)

24.5 (1.5)

0.67

Lactate (mmol/l)

1.37 (0.5)

1 (0.5)

1.2 (0.5)

0.13

1.3 (0.3)

1.1 (0.8)

1.2 (0.6)

0.17

Physical performance

N = 11

N = 11

N = 22

 

N = 6

N = 4

N = 10

 

6MWT-Distance (m)

454.6 (101.6)

535.5 (67.9)

495 (94)

0.08

502.2 (81)

519 (22.7)

508.9 (62.4)

1.00

6MWT-Perceived exertion-BS

1.3 (2.1)

1.8 (2.8)

1.6 (2.4)

0.68

3.2 (2.2)

3.2 (3.9)

3.2 (2.9)

0.80

6MWT-Perceived dyspnea-BS

2.9 (2.8)

5 (3.3)

4 (3.2)

0.13

4.5 (1.9)

4.5 (3.9)

4.5 (2.6)

1.00

6MWT-SpO2 (%)

96.1 (3.3)

93.9 (4.2)

95 (3.8)

0.21

96 (4.5)

95.8 (5.4)

95.9 (4.6)

0.66

6MWT-Heart rate (bpm)

109.6 (13.9)

110.5 (24.5)

110.1 (19.7)

0.65

111.8 (7.6)

107.2 (14)

110 (10.1)

0.91

  1. Data are presented as mean (standard deviation) or number (%), unless indicated otherwise. BS Borg scale. bpm beats per minute. DLCO diffusing capacity for carbon monoxide. FEV1 forced expiratory volume in 1 s. FVC forced vital capacity. HRCT high-resolution computed tomography. MEP maximal expiratory pressure. MIP maximal inspiratory pressure. RV residual volume. SNIP sniff nasal inspiratory pressure. Sp02 oxygen pulsed saturation. SVC slow vital capacity. TLC total lung capacity. UC-MSCs umbilical cord-derived mesenchymal stromal cells. VAS visual analogue scale. VC vital capacity. 6MWT 6-min walking test
  2. *In the placebo group, one patient did not undergo plethysmography
  3. **Analyses were conducted comparing UC-MSCs and placebo at both six and twelve months using Wilcoxon rank-sum test for continuous data and Fisher exact test for categorical data
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Stem Cell Research & Therapy

ISSN: 1757-6512