Abstract

Injection of adipose tissue-derived stem cells (ASCs) is a novel method for the treatment of complex perianal fistulas. We aimed to evaluate the safety and efficacy of ASCs in the treatment of complex anal fistulas not associated with Crohn's disease. A phase II clinical trial was performed comparing two different doses of ASCs (group 1: 1×107cells/mL and group 2: 2×107cells/mL). Eligible patients were administered an amount of ASCs proportional to the length of the fistula by injection into the submucosal layer surrounding the internal opening and inside of the fistula tract. ASCs at twice the initial concentration were administered if complete closure was not achieved within 8weeks. The efficacy endpoint was the complete closure of fistulas 8weeks after injection. Patients demonstrating complete closure at week 8 were subjected to follow-up for 6months. Fifteen patients were injected with ASCs; thirteen completed the study. Complete closure was observed in 69.2% (9/13) of patients at 8weeks. Three of five patients in group 1, and six of eight in group 2 displayed complete closure; no significant differences were observed between the groups. Six of nine patients who showed complete closure participated in additional follow-up; five (83.3%) showed persistent response at 6months. No grade 3 or 4 adverse events (AEs) were observed; observed AEs were not related to ASC treatment. ASCs might be a good option for the treatment of complex perianal fistulas are not healed by conventional operative procedures.

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