Recurrent anal fistulae: Limited surgery supported by stem cells

Table 2 Published studies on stem cell therapy for anal fistulae

Ref.	Year	Condition	Study design	Cell source	Cell quantity (dose)	Intervention model
García-Olmo et al[11]	2003	Recto-vaginal fistula in Crohn’s disease	Case report	Autologous eASC	1 × 107	Single arm
García-Olmo et al[12]	2005	Enterocutaneous, recto-vaginal, perianal fistula in Crohn’s disease	Phase I	Autologous eASC	1-3 × 107 re-suspended in fibrin glue	Single arm
García-Olmo et al[13]	2009	Perianal fistula with or without Crohn’s disease	Phase II	Autologous eASC	Not specified	Two arms: fibrin glue, fibrin glue + eASC
García-Olmo et al[22]	2010	Recto-vaginal fistula in Crohn’s disease	Case report	Allogenic eASC	Not specified	Single arm
Ciccocioppo et al[25]	2011	Enterocutaneous and complex perianal fistula in Crohn's disease	Case report	Expanded autologous bone marrow	5 × 107	Single arm
Cho et al[24]	2012	Perianal fistula in Crohn’s disease	Phase I	Autologous eASC	Not specified	Single arm: dose escalation study
Herreros et al[14]	2012	Complex perianal fistula without Crohn’s disease	Phase III	Autologous eASC	2 × 107 then 4 × 107 if no effect	Three arms: fibrin glue, eASC, fibrin glue + eASC
Herreros et al[14]	2012	Complex perianal fistula without Crohn’s disease	Observational	Autologous eASC	2 × 107 then 4 × 107 if no effect	Three arms: fibrin glue, eASC, fibrin glue + eASC
Guadalajara et al[23]	2012	Perianal fistula with or without Crohn’s disease	Observational	Autologous eASC	Not specified	Two arms: fibrin glue, fibrin glue + eASC
de la Portilla et al[17]	2012	Perianal fistula in Crohn’s disease	Phase I/II	Allogeneic eASC	2 × 107 then 4 × 107 if no effect	Single arm
Lee et al[20]	2013	Perianal fistula in Crohn’s disease	Phase II	Autologous eASC	Depending on the fistula. Re-dosing (1.5 times) if no effect	Single arm

SAE: Serious adverse events (those requiring hospital admission > 24 h); eASC: Expanded adult stem cells.