Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Follow-up Study of Autologous Cultured Adipose-derived Stem Cells for the Crohn's Fistula (ANTG-ASC-203)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anterogen Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01314079
First received: March 8, 2011
Last updated: November 21, 2016
Last verified: March 2012

March 8, 2011
November 21, 2016
April 2010
August 2012   (final data collection date for primary outcome measure)
Number of patients with Sustained efficacy of complete closure of fistula [ Time Frame: Month 4, 10 ] [ Designated as safety issue: No ]
Proportion of patients whose fistula has been completely closed.
Number of patients with Sustained efficacy of complete closure of fistula [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Proportion of patients whose fistula has been completely closed.
Complete list of historical versions of study NCT01314079 on ClinicalTrials.gov Archive Site
  • Number of patients with sustained efficacy of closure of fistula [ Time Frame: Month 2, 4, 10 ] [ Designated as safety issue: No ]
    Proportion of patients with more than 50% closed of fistula (Month 2, 4, 10)
  • Number of patients with any adverse event [ Time Frame: Month 2, 4, 10 ] [ Designated as safety issue: Yes ]
    number of patients with any adverse event (Month 2, 4, 10)
  • Grade of Investigator's satisfaction [ Time Frame: Month 2, 4, 10 ] [ Designated as safety issue: No ]

    Grade of Investigator's satisfaction (Month 2, 4, 10)

    1. very satisfaction
    2. satisfacttion
    3. somewhat satisfaction
    4. unsatisfaction
    5. very unsatisfaction
  • Number of patients with sustained efficacy of closure of fistula [ Time Frame: 2, 4 months ] [ Designated as safety issue: No ]
    Proportion of patients with complete closure of fistula (2 months) Proportion of patients with more than 50% closed of fistula (2, 4 monts)
  • Number of patients with any adverse event [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    number of patients with any adverse event (every visits)
  • Grade of Investigator's satisfaction [ Time Frame: 2, 4 months ] [ Designated as safety issue: No ]

    Grade of Investigator's satisfaction (2, 4 months)

    1. very satisfaction
    2. satisfacttion
    3. somewhat satisfaction
    4. unsatisfaction
    5. very unsatisfaction
Not Provided
Not Provided
 
Follow-up Study of Autologous Cultured Adipose-derived Stem Cells for the Crohn's Fistula
Follow-up Study to Evaluate the Sustained Efficacy and Safety for the Patients With Adipoplus Injected in Phase II Clinical Trials(ANTG-ASC-202)
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.
Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
The patients who have participated in phase II clinical trial (ANTG-ASC-202) and injected with Adipoplus at least once.
  • Crohn's Disease
  • Fistula
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
August 2012
August 2012   (final data collection date for primary outcome measure)

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:

  • 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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01314079
ANTG-ASC-203
No
Not Provided
Not Provided
Anterogen Co., Ltd.
Anterogen Co., Ltd.
Not Provided
Principal Investigator: CS You, MD, PhD Asan Medical Center
Anterogen Co., Ltd.
March 2012

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