Table 1: Published clinical experiences of cell treatments of anal fistula (Part 1). An update of the tables taken from the section “Stem Cell Application in Fistula Disease” [33].

Investigators

Year of publication

Trial code

Location

Condition

Study design

Cell source

Expanded

Cells number

García-Olmo et al. [34]

2003

NA

Spain

Recto-vaginal fistula in Crohn’s disease

Case report

Autologous fat

Yes

1 × 10e7

García-Olmo et al. [41]

2005

Not registered

Spain

Enterocutaneous, recto-vaginal, perianal fistula in Crohn’s disease

Phase I

Autologous fat

Yes

1-3 × 10e7 resuspended in fibrin glue

García-Olmo et al. [25]

2009

NCT00115466

Spain

Perianal fistula with or without Crohn’s disease

Phase II

Autologous fat

Yes

Not specified

García-Olmo et al. [40]

2010

NA

Spain

Recto-vaginal fistula in Crohn’s disease

Case report

Allogeneic fat

Yes

Not specified

Ciccocioppo et al. [39]

2011

NA

Italy

Enterocutaneous, complex perianal fistula in Crohn’s disease

Case report

Autologous bone marrow

Yes

5 × 10e7

Herreros et al. [27]

2012

NCT00475410

Spain

Complex perianal fistula without Crohn’s disease

Phase III

Autologous fat

Yes

2 × 10e7 then

4 × 10e7 when no effect

Herreros et al. [27]

2012

NCT01020825

Spain

Perianal fistula with or without Crohn’s disease

Observational

Autologous fat

Yes

2 × 10e7 then

4 × 10e7 when no effect

Guadalajara et al. [42]

2012

Not registered

Spain

Perianal fistula with or without Crohn’s disease

Observational

Autologous fat

Yes

Not specified

Borowski et al. [35]

2012

NA

UK

Perianal fistula without Crohn’s disease

Case report

Autologous fat

No

Not specified

de la Portilla et al. [37]

2013

NCT01372969

Spain

Perianal fistula in Crohn’s disease

Phase I/II

Allogeneic fat

Yes

2 × 10e7 then

4 × 10e7 when no effect

Cho et al. [38]

2013

NCT00992485

Korea

Complex perianal fistula in Crohn’s disease

Phase I

Autologous fat

Yes

1 × 10e7,

2 × 10e7,

4 × 10e7

Lee et al. [36]

2013

NCT01011244

Korea

Complex perianal fistula in Crohn’s disease

Phase II

Autologous fat

Yes

3 × 10e7 per cm length of the fistula. Initial dose  ×  1.5 when no effect

Cho et al. [43]

2015

NCT01011244 long term

Korea

Complex perianal fistula in Crohn’s disease

Phase II

Autologous fat

Yes

3 × 10e7 per cm length of the fistula. Initial dose  ×  1.5 when no effect

Ciccocioppo et al. [44]

2015

NA

Italy

Enterocutaneous, complex perianal fistula in Crohn’s disease

Case report

Autologous bone marrow

Yes

5 × 10e7

García-Olmo et al. [45]

2015

NA

Spain

Complex perianal fistula with or without Crohn’s disease

Case report

Autologous fat

Both

Not specified

Molendijk et al. [24]

2015

NCT01144962

Netherlands

Perianal fistula in Crohn's disease

Phase I/II

Allogeneic bone marrow

Yes

1 × 10e7,

3 × 10e7,

9 × 10e7

Borowski et al. [46]

2015

NA

UK

Perianal fistula without Crohn’s disease

Case report

Autologous fat

No

Not specified

Park KJ. [47]

2015

NCT01440699

Korea

Perianal fistula in Crohn's disease

Phase I

Allogeneic fat

Yes

1 × 10e7,

3 × 10e7