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 |