Treatment procedure
fistula
DISEASE, ABSCESSES
A pelvic MRI scan was performed at the screening to guide the surgical procedure and to assess abscesses. Two weeks before cell administration, patients might be treated with fistula curettage and seton placement under anesthesia.If a seton was placed, it was withdrawn immediately before cell administration. Closure of the internal opening was achieved using polyglactin absorbable 2/0 stitches and confirmed by injection of 10 mL saline solution through the external opening. Subsequently, 120 million cells were injected with a 22G needle into tissues adjacent to all fistula tracts and the internal opening. This dose was selected according to the studies with Darvadstrocel. Half of the cells were injected via the anal canal into the tissues surrounding the sutured internal opening, and the other half of cells were injected through the external opening (s) into the fistula walls (no deeper than 2 mm) along the fistula tract (s) (Fig. Treatment procedure. (During the study, patients could be treated with antibiotics. Immunomodulators and anti-TNF mAbs were maintained at stable doses. A steroid course was permitted to treat occurrences of luminal disease during the study, with a starting dose of 40 mg tapered over a maximum of 12 weeks.Patients were followed up at weeks 1, 2, 4, 12, 24 and 52. Outcomes were assessed by masked investigators at baseline and all study visits. Pelvic MRI was performed at 12 weeks and 24 weeks [