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The treatment of fistula is designed to eradicate fistula, preserve sphides, prevent recurrence and allow patients to resume daily activities at an early time.
the difficulty of achieving these goals, stem cell-based therapies have emerged to treat complex fistulas, with encouraging results.
, the purpose of this study was to assess the safety of allogeneic interstumogenous stem cells in treating complex fistulas in patients without Crohn's disease.
the study as a forward-looking non-randomized Phase I clinical trial that included a total of 20 non-Crohn's patients diagnosed with complex fistula.
all patients received 40×106 allogeneic interstate-filled stem cells.
in patients with 2 sinus channels, 20 to 106 stem cells × each sinus.
patients were discharged 24 hours after surgery and evaluated 1, 2, 4, 8, 16 and 24 weeks after application.
20 patients underwent the procedure between 1 October 2016 and 31 October 2017; One patient was excluded from the final data analysis.
no adverse reactions were reported within the first 24 hours, and all patients were asymptomatic.
three patients (15%) developed abscesses.
one patient developed an abscess in the fourth week and two others were diagnosed with an abscess in week 8.
13 patients (69%) were completely closed.
the study, the authors confirmed that it was safe to use isogenetically charged stem cells as a treatment for complex fistulas unrelated to Crohn's disease.