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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01314079
First Posted: March 14, 2011
Last Update Posted: November 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Anterogen Co., Ltd.
  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:


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

  • Grade of Investigator's satisfaction [ Time Frame: Month 2, 4, 10 ]

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

    1. very satisfaction
    2. satisfacttion
    3. somewhat satisfaction
    4. unsatisfaction
    5. very unsatisfaction


Enrollment: 37
Study Start Date: April 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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.
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01314079


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

Responsible Party: Anterogen Co., Ltd.
ClinicalTrials.gov Identifier: NCT01314079     History of Changes
Other Study ID Numbers: ANTG-ASC-203
First Submitted: March 8, 2011
First Posted: March 14, 2011
Last Update Posted: November 23, 2016
Last Verified: March 2012

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