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

November 21, 2016 updated by: Anterogen Co., Ltd.

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

37

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Month 4, 10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)
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
Month 2, 4, 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anterogen Co., Ltd.

Investigators

  • Principal Investigator: CS You, MD, PhD, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

March 8, 2011

First Submitted That Met QC Criteria

March 11, 2011

First Posted (Estimate)

March 14, 2011

Study Record Updates

Last Update Posted (Estimate)

November 23, 2016

Last Update Submitted That Met QC Criteria

November 21, 2016

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANTG-ASC-203

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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