Trials / Completed
CompletedNCT01011244
Safety and Efficacy Study of Autologous Cultured Adipose -Derived Stem Cells for the Crohn's Fistula
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
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Anterogen Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ADIPOPLUS | autologous cultured adipose-derived stem cells 1x10e7 cells/1cm2 depending on surface area of fistula |
Timeline
- Start date
- 2010-02-01
- Primary completion
- 2011-09-01
- Completion
- 2011-09-01
- First posted
- 2009-11-11
- Last updated
- 2012-03-15
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01011244. Inclusion in this directory is not an endorsement.