Long-Term Results of Adipose-Derived Stem Cell Therapy for the Treatment of Crohn's Fistula

Abstract 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. Significance Long-term follow-up of patients with Crohn's fistula found that one or two doses of autologous adipose-derived stem cell therapy achieved complete closure in 80% of the patients at 12 months. After 24 months, 75% of those patients sustained complete closure, showing sustainable safety and efficacy of the treatment.