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CompletedNCT00992485Updated May 10, 2010

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

A Phase 1 interventional study of ADIPOPLUS in Crohn's Fistula, sponsored by Anterogen Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-05-10.

Sponsored by Anterogen Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Crohn's Fistula

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03

In context

Fistula

731 studies on the registry are indexed under Fistula; 103 are open to participants now.

This study's enrollment of 9 is below the median of 60 across 484 interventional studies indexed under Fistula.

Browse Fistula studies →

Lead sponsor

Anterogen Co., Ltd. is the lead sponsor of 30 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    autologous adipose derived stem cell

    Drug: ADIPOPLUS

Interventions

  • DrugADIPOPLUS

    autologous adipose-derived stem cell

06

What researchers measure

Primary outcomes

  1. Efficacy: closure of fistula at week 8 Safety: - Clinically measured abnormality of laboratory tests and adverse events

Secondary outcomes

  1. Closure of fistula

    Time frame: week 4

  2. Investigator satisfaction

    Time frame: week 4 and week 8

  3. Patient satisfaction

    Time frame: week 4 and week 8

  4. Digital photography

    Time frame: day 1, week 4 and week 8

07

Study locations

1 site
  • Asan medical center
    Seoul, 138-736, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 10, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00992485
Lead sponsor
Anterogen Co., Ltd.
First posted
Oct 9, 2009
Start date
Nov 2008
Primary completion
Sep 2009
Completion
Mar 2010
Last update
May 10, 2010
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2010. You cannot join it, but the record below documents what was studied.

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