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

Crohn's Fistula Clinical Trial

Official title: A Phase II Clinical Study of ADIPOPLUS (Autologous Cultured Adipose-derived Stem Cell) for the Treatment of Crohn's Fistula to Evaluate Safety and Efficacy

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn's Fistula
• Fistula

• NCT number: NCT01011244
• Study type: Interventional
• Source: Anterogen Co., Ltd.
• Status: Completed
• Phase: Phase 2
• Start date: February 2010
• Completion date: September 2011