Retrospective Study
Copyright ©The Author(s) 2021.
World J Gastroenterol. Jun 28, 2021; 27(24): 3643-3653
Published online Jun 28, 2021. doi: 10.3748/wjg.v27.i24.3643
Table 1 Inclusion and exclusion criteria for administration of darvadstrocel
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 injectionNo medical, biological or surgical therapy prior to stem cell injection
No active Crohn’s disease confirmed by ileocolonoscopyActive Crohn’s disease confirmed by ileocolonoscopy
No perianal abscess or sepsis confirmed by clinical exam, endoanal ultrasound and/or pelvic MRIPerianal abscess or significant inflammation in the pelvis or anorectal region confirmed by MRI
Interdisciplinary recommendationNo recommendation by multidisciplinary team
Patient compliant for medical consultation, follow-up examination and interdisciplinary monitoring of diseaseNon-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 stenosisPresence of anorectal stenosis
Fully informed consent possibleNo informed consent possible