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

This study is ongoing, but not recruiting participants.
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
History of Changes
  Purpose

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.


Condition
Crohn's Disease
Fistula

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Follow-up Study to Evaluate the Sustained Efficacy and Safety for the Patients With Adipoplus Injected in Phase II Clinical Trials(ANTG-ASC-202)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Anterogen Co., Ltd.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 40
Study Start Date: April 2010
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01314079

Locations
Korea, Republic of
Seoul Asan Hospital
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
DaeHang Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Anterogen Co., Ltd.
Investigators
Principal Investigator: CS You, MD, PhD Asan Medical Center
  More Information

No publications provided

Responsible Party: Anterogen Co., Ltd.
ClinicalTrials.gov Identifier: NCT01314079     History of Changes
Other Study ID Numbers: ANTG-ASC-203
Study First Received: March 8, 2011
Last Updated: March 14, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Anterogen Co., Ltd.:
Crohn's fistula
Autologous adipose derived stem cell

Additional relevant MeSH terms:
Crohn Disease
Fistula
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 22, 2013