Trials / Completed
CompletedNCT00992485
Safety and Efficacy Study of Autologous Cultured Adipose -Derived Stem Cells for the Crohn's Fistula
A Phase I Dose Escalation 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 1
- Study type
- Interventional
- Enrollment
- 9 (actual)
- 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 has not known and the fistula recurrence rate is high. On 15 October 2008, orphan drug designation was granted by Korea FDA to Anterogen Co. Ltd., for human adipose-derived stem cell. In this study, patients are given injection of ADIPOPLUS in fistula site and followed for 8 weeks to test the safety and efficacy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ADIPOPLUS | autologous adipose-derived stem cell |
Timeline
- Start date
- 2008-11-01
- Primary completion
- 2009-09-01
- Completion
- 2010-03-01
- First posted
- 2009-10-09
- Last updated
- 2010-05-10
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT00992485. Inclusion in this directory is not an endorsement.