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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00992485
Recruitment Status : Completed
First Posted : October 9, 2009
Last Update Posted : May 10, 2010
Information provided by:
Anterogen Co., Ltd.

September 29, 2009
October 9, 2009
May 10, 2010
November 2008
September 2009   (Final data collection date for primary outcome measure)
Efficacy: closure of fistula at week 8 Safety: - Clinically measured abnormality of laboratory tests and adverse events
Same as current
Complete list of historical versions of study NCT00992485 on Archive Site
  • Closure of fistula [ Time Frame: week 4 ]
  • Investigator satisfaction [ Time Frame: week 4 and week 8 ]
  • Patient satisfaction [ Time Frame: week 4 and week 8 ]
  • Digital photography [ Time Frame: day 1, week 4 and week 8 ]
Same as current
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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
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.
Not Provided
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Crohn's Fistula
autologous adipose-derived stem cell
Experimental: autologous adipose derived stem cell
Intervention: Drug: ADIPOPLUS
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2010
September 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Older than 18 years
  • Prior diagnosis of Crohn's disease
  • patients who have Crohn's fistula
  • negative for urine beta-HCG for woman of childbearing age
  • agreement to participate, with signed informed-consent

Exclusion Criteria:

  • patients who have allergy to bovine-derived materials or an anesthetic
  • patients with a diagnosis of auto immune disease except for Crohn's disease
  • Diagnosis of HBV, HCV, HIV and other infectious disease
  • Patients who have a symptom of septicemia
  • Patients with a diagnosis of active Tuberculosis
  • Patients who are pregnant or breast-feeding
  • Patients who are unwilling to use an "effective" method of contraception during the study
  • Patients with a diagnosis of Inflammatory Bowel Disease except for Crohn's disease
  • Patients who is sensitive to Fibrin glue
  • Patients who have a clinically relevant history of abuse of alcohol or drugs
  • Insufficient adipose tissue for manufacturing of ADIPOPLUS
  • Patients who are considered not suitable for the study by investigator
  • Patients who have history of surgery for malignant cancer in the past 5 years
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
Not Provided
Not Provided
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Mihyung Kim, Director
Anterogen Co., Ltd.
Not Provided
Not Provided
Anterogen Co., Ltd.
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP