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CompletedNCT01314079ANTG-ASC-203Updated Nov 23, 2016

Follow-up Study of Autologous Cultured Adipose-derived Stem Cells for the Crohn's Fistula

An observational study in Crohn's Disease and Fistula, sponsored by Anterogen Co., Ltd.. Completed at 3 sites in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-23.

Sponsored by Anterogen Co., Ltd. · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
37
Ages
18 Years and older
Sex
All
01

Study summary

This is an open follow-up clinical trials to evaluate a sustained efficacy and safety of Adipoplus inj. for 10 months (12 months after final dose injection)after Phase II clinical trial.

02

Conditions studied

  • Crohn's Disease
  • Fistula

Keywords

  • Crohn's fistula
  • Autologous adipose derived stem cell
03

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's enrollment of 37 is below the median of 162 across 608 observational studies indexed under Crohn Disease.

Browse Crohn Disease 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
Sampling method
Non-probability sample

Study population

The patients who have participated in phase II clinical trial (ANTG-ASC-202) and injected with Adipoplus at least once.

Inclusion criteria

  • the patients who have participated in ANTG-ASC-202 clinical trial
  • the patients who have experienced with Adipoplus in ANTG-ASC-202 trials
  • the patients who submit written consents and is able to obey requirements of trials

Exclusion criteria

Exclusion Criteria:

  • pregnant or breast feeding
  • autoimmune disease other than Crohn's disease
  • infectious diseases including HBV, HCV or HIV
  • who is not willing to use effective contraceptive methods during the study.
  • active tuberculosis
  • moderate to severe active or worsened Crohn's disease
  • who have received Infliximab during or after ANTG-ASC-202 trial
05

Study design

Time perspective
Prospective
Enrollment
37 participants (actual)
06

What researchers measure

Primary outcomes

  1. Number of patients with Sustained efficacy of complete closure of fistula

    Proportion of patients whose fistula has been completely closed.

    Time frame: Month 4, 10

Secondary outcomes

  1. Number of patients with sustained efficacy of closure of fistula

    Proportion of patients with more than 50% closed of fistula (Month 2, 4, 10)

    Time frame: Month 2, 4, 10

  2. Number of patients with any adverse event

    number of patients with any adverse event (Month 2, 4, 10)

    Time frame: Month 2, 4, 10

  3. Grade of Investigator's satisfaction

    Grade of Investigator's satisfaction (Month 2, 4, 10) 1. very satisfaction 2. satisfacttion 3. somewhat satisfaction 4. unsatisfaction 5. very unsatisfaction

    Time frame: Month 2, 4, 10

07

Study locations

3 sites
  • DaeHang Hospital
    Seoul, Korea, Republic of
  • Samsung Medical Center
    Seoul, Korea, Republic of
  • Seoul Asan Hospital
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 23, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01314079
Lead sponsor
Anterogen Co., Ltd.
Responsible party
Sponsor
First posted
Mar 14, 2011
Start date
Apr 2010
Primary completion
Aug 2012
Completion
Aug 2012
Last update
Nov 23, 2016

Study contacts

CS You, MD, PhD
principal investigator · Asan Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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