drugset / Trial / NCT01011244

Safety and Efficacy Study of Autologous Cultured Adipose -Derived Stem Cells for the Crohn's Fistula

NCT01011244 ↗

Phase 2 Completed 40 enrolled Anterogen Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

Up to date, a sure cure for Crohn's fistula does not known and the fistula recurrence rate is high. On 15 October 2008, orphan designation was granted by Korea FDA for human adipose-derived stem cell (ADIPOPLUS) for the treatment of Crohn's fistula. In this study, patients are given injection of ADIPOPLUS in fistula site and followed for 8 weeks to evaluate the safety and efficacy.

Timeline

Start
2010-02
Primary completion
2011-09
Completion
2011-09

Drugs

EvaluationDrugModalityDoseRoute
Subject ADIPOPLUS Cell therapy 1e+07 cells Other

Indications