Research Papers

Autologous Adipose Tissue-derived Stem Cells Treatment Demonstrated Favorable and Sustainable Therapeutic Effect for Crohn's Fi

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Date

2015-05-11 22:25

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Autologous Adipose Tissue-derived Stem Cells Treatment
Demonstrated Favorable and Sustainable Therapeutic Effect for
Crohn's Fistula 2012

ABSTRACT
Fistula is a representative devastating complication in Crohn’s patients due to refractory to conventional therapy and high recurrence. In our phase I clinical trial, adipose tissue-derived stem cells (ASCs) demonstrated their safety and therapeutic potential for healing fistulae associated with Crohn's disease.
This study was carried out to evaluate the efficacy and safety of ASCs in patients with Crohn's fistulae.In this phase II study, forty-three patients were treated with ASCs. The amount of ASCs was proportioned to fistula size and fistula tract was filled with ASCs in combination with fibrin glue after intralesional injection of ASCs. Patients without complete closure of fistula at 8 weeks received a second injection of ASCs containing 1.5 times more cells than the first injection. Fistula healing at week 8 after final dose injection and its sustainability for 1 year were evaluated. Healing was defined as a
complete closure of external opening without any sign of drainage and inflammation. A modified perprotocol (mPP) analysis showed that complete fistula healing was observed in 27/33 patients (82%) by 8 weeks after ASC injection. Of 27 patients with fistula healing, 26 patients completed additional observation study for 1 year and 23 patients (88%) sustained complete closure. There were no adverse events related to ASC administration. ASC treatment for patients with Crohn’s fistulae was well-tolerated,
with a favorable therapeutic outcome. Further, complete closure was well-sustained. These results strongly suggest that autologous ASC could be a novel treatment option for the Crohn’s fistula with high risk of recurrence.

Figure 1. Patient Disposition

CONCLUSION
ASCs treatment, with dose scheme proportional to fistula’s surface area, produced a favorable therapeutic outcome, good tolerability and safety in the patients with Crohn’s fistula for longer than 1 year.