A previous phase II clinical trial of adipose-derived stem cell (ASC) therapy for fistulae associated with Crohn's disease, a devastating condition with a high recurrence rate, demonstrated safety and therapeutic potential with a 1-year sustained response. In the present study, 41 of the 43 phase II trial patients were followed for an additional year, regardless of response in the initial year. At 24 months, complete healing was observed in 21 of 26 patients (80.8%) in modified per protocol analysis and 27 of 36 patients (75.0%) in modified intention-to-treat analysis. No adverse events related to ASC administration were observed. Furthermore, complete closure after initial treatment was well-sustained. These results strongly suggest that autologous ASCs may be a novel treatment option for Crohn's fistulae.
Keywords: Adipose-derived stem cells; Autologous stem cells; Complete closure of fistula; Crohn’s fistula; Sustained response.
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