Stem cell injection for complex anal fistula in Crohn’s disease: A single-center experience

Table 1 Inclusion and exclusion criteria for administration of darvadstrocel

Inclusion	Exclusion
Complex anal fistulas associated with Crohn’s disease (including horse-shoe fistula)	Simple fistulas associated with Crohn’s disease, rectovaginal fistula
At least one conventional, biological or surgical therapy prior to stem cell injection	No medical, biological or surgical therapy prior to stem cell injection
No active Crohn’s disease confirmed by ileocolonoscopy	Active Crohn’s disease confirmed by ileocolonoscopy
No perianal abscess or sepsis confirmed by clinical exam, endoanal ultrasound and/or pelvic MRI	Perianal abscess or significant inflammation in the pelvis or anorectal region confirmed by MRI
Interdisciplinary recommendation	No recommendation by multidisciplinary team
Patient compliant for medical consultation, follow-up examination and interdisciplinary monitoring of disease	Non-compliance of patient
Pretreatment of fistulas by seton drainage (“conditioning”)	Fistulas without seton drainage or conditioning by curettage
Maximum of two fistulas with two internal and two external openings (each)	More than two complex fistulas
No anorectal stenosis	Presence of anorectal stenosis
Fully informed consent possible	No informed consent possible

MRI: Magnetic resonance imaging.