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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.

SUBMITTER: Cho YB 

PROVIDER: S-EPMC4414218 | biostudies-literature | 2015 May

REPOSITORIES: biostudies-literature

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Long-term results of adipose-derived stem cell therapy for the treatment of Crohn's fistula.

Cho Yong Beom YB   Park Kyu Joo KJ   Yoon Sang Nam SN   Song Kee Ho KH   Kim Do Sun DS   Jung Sang Hun SH   Kim Mihyung M   Jeong Hee Young HY   Yu Chang Sik CS  

Stem cells translational medicine 20150331 5


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 anal  ...[more]

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