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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Anterogen Co., Ltd..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Anterogen Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01314079
First received: March 8, 2011
Last updated: March 14, 2012
Last verified: March 2012

March 8, 2011
March 14, 2012
April 2010
Not Provided
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.
 
Active, not recruiting
40
Not Provided
Not Provided

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
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01314079
ANTG-ASC-203
No
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