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Table 2 Characteristics of North America/European and Other countries

From: Clinical trials of stem cell-based therapies for pediatric diseases: a comprehensive analysis of trials registered on ClinicalTrials.gov and the ICTRP portal site

  

North America and European (n = 105)

Other (n = 97)

χ2/Fisher

P

Submitted year

Prior to 2003

6 (5.7%)

0 (0)

36.324

 < 0.001

 

2003–2007

18 (17.1%)

0 (0)

  
 

2008–2012

29 (27.6%)

16 (16.5%)

  
 

2013–2017

28 (26.7%)

32 (33.0%)

  
 

2018-mid2021

24 (22.9%)

49 (50.5%)

  

Publication

No

83 (79.0%)

78 (80.4%)

0.058

0.810

 

Yes

22 (21.0%)

19 (19.6%)

  

Sponsor

University and Hospital

42 (40.0%)

62 (63.9%)

11.738

0.008

 

Industry

26 (24.8%)

16 (16.5%)

  
 

NPO

28 (26.7%)

14 (14.4%)

  
 

Other

9 (8.6%)

5 (5.2%)

  

Location

Multicountry-multicenter

16 (15.2%)

0 (0)

20.152

 < 0.001

 

Single center

62 (59.0%)

71 (73.2%)

  
 

Single country-multicenter

23 (21.9%)

16 (16.5%)

  
 

NA

4 (3.8%)

10 (10.3%)

  

Estimated Enrollment

 < 50

79 (75.2%)

65 (67.0%)

7.151

0.128

 

50 ≤ n < 100

12 (11.4%)

18 (18.6%)

  
 

100 ≤ n < 200

6 (5.7%)

7 (7.2%)

  
 

 ≥ 200

4 (3.8%)

7 (7.2%)

  
 

NA

4 (3.8%)

0 (0)

  

Gender

All

98 (93.3%)

91 (93.8%)

0.019

0.889

 

Male only

7 (6.7%)

6 (6.2%)

  

DMC

No

23 (21.9%)

22 (22.7%)

3.234

0.199

 

Yes

66 (62.9%)

51 (52.6%)

  
 

Not provided

16 (15.2%)

24 (24.7%)

  

Study type

Interventional

100 (95.2%)

86 (88.7%)

2.992

0.084

 

Observational

5 (4.8%)

11 (11.3%)

  

Named product

No

83 (79.0%)

89 (91.8%)

13.873

0.011

 

Yes

22 (21.0%)

8 (8.2%)

  

Combination therapy

No

67 (63.8%)

79 (81.4%)

7.825

0.005

 

Yes

38 (36.2%)

18 (18.6%)

  

Autologous/allogeneic

Allogeneic

46 (43.8%)

37 (38.1%)

8.144

0.043

 

Autologous

46 (43.8%)

33 (34.0%)

  
 

Allogeneic + autologous

0 (0)

1 (1.0%)

  
 

NA

13 (12.4%)

26 (26.8%)

  
  1.  * NA, not available