Table 1 Characteristics of included studies evaluating the efficacy and safety of stem cell therapy for patients with Crohn’s disease

Burt et al. 2010 [9]

24

12:12

27

10

Y

Y

Y

71% (17/24)

N

N

Y

-

235

Phase I/IIa open label, single arm

USA

Cassinotti et al. 2012 [43]

10

7:3

-

-

-

-

-

-

-

-

-

-

Phase I/IIa open label, single arm

Italy

Hasselblatt et al. 2012 [10]

12

8:4

36.5 (range 24–50)

12.7 (range 2–24)

Y

Y

Y

8

Y

Y

Y

Y

285 ± 79

Phase I/IIa open label, single arm

Germany

Hawkey et al. 2015 [13]

23

11:13

Median 34.1

14.9 (IQR,9.9-16.9)

-

-

N

2 (IQR,0.5–3.5)

N

N

N

-

326 (range 251–414)

RCT, multicenter

European

Onken et al. 2006 [27]

10

-

-

-

-

-

-

-

-

-

-

-

-

Phase II, open label, double arm, randomized

USA

Duijvestein et al. 2010 [29]

10

2:8

Median 32.5

3 ~ 12

Y

Y

Y

4

Y

N

Y

Y

Median 299.5 (range 255–442)

Phase I, open label, single arm

Netherlands

Forbes et al. 2014 [36]

16

6:10

21–55

-

-

Y

-

3

Y

N

Y

-

>250

Phase II, open label, single arm multicenter

Australia

Lazebnik et al. 2010 [30]

50 (11 CD)

-

-

-

-

-

-

-

N

N

Y

-

261.5 ± 18.2 (range 206–298)

Open label, double arm

Russia

Dhere et al. 2016 [40]

12

6:6

18–52

-

Y

Y

N

-

N

N

N

-

>220

Phase I

USA

Garcia-Olmo et al. 2005 [16]

5

3:2

35.1 ± 2.4

-

Y

Y

Y

Y

N

N

N

N

-

Phase I, open label, single arm

Spain

Garcia-Olmo et al. 2009 [28]

49 (14 CD)

10:14

42.64 ± 10.93

-

6 (25)

N

-

Fistula:17 (71)

-

-

-

-

-

Phase II, open label, double arm, randomized

Spain

Ciccocioppo et al. 2011 [31]

12

8:4

Median 32

-

Y

Y

Y

Y

Y

N

Y

Y

294 ± 49

Open label, single arm

Italy

Park et al. 2012 [32]

11

6:5

24.6

-

-

5

-

-

-

-

-

-

-

Phase I/IIa open label, single arm

Korea

de la Portilla et al. 2013 [34]

24

11:13

36 ± 9

-

-

-

-

-

Y

N

Y

Y

-

Phase I/IIa open label, single arm

Spain

Cho et al. 2013 [33]

10

4:6

26.5 ± 6

-

-

-

-

-

-

-

-

-

-

Phase I, open label, single arm

Korea

Lee et al. 2013 [35]

33

22:11

26.7 ± 5.6

54.6 ± 40.1 months

-

-

-

-

41 (95.3)

-

-

-

-

Phase II, open label, single arm

Korea

Park et al. 2014 [37]

6

-

-

-

-

-

-

-

-

-

-

-

-

Multicenter, randomized phase I/IIa

Korea

Cho et al. 2015 [38]

41

28:13

26.2 ± 5.5

-

-

-

-

-

-

-

-

-

-

f/u of phase II

Korea

Molendijk et al. 2015 [39]

21

-

-

-

-

-

-

-

-

-

-

-

-

Double-blind RCT

Netherlands

Lightner et al. 2016 [41]

7

3:4

31

4.5

Y

Y

Y

Y

-

-

-

-

-

Phase I

USA

Panés et al. 2016 [42]

212

60:47

39 ± 13

12.1 ± 10

89 (83%)

83 (78%)

6/103 (5%)

-

44 (41%)

37 (35%)

6/103 (5%)

-

88.7 ± 48.8

Phase III double-blind RCT multicenter

European, Israel