This trial is active, not recruiting.

Conditions crohn's disease, fistula
Sponsor Anterogen Co., Ltd.
Start date April 2010
Trial size 40 participants
Trial identifier NCT01314079, ANTG-ASC-203


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective

Primary Outcomes

Number of patients with Sustained efficacy of complete closure of fistula
time frame: Month 4, 10

Secondary Outcomes

Number of patients with sustained efficacy of closure of fistula
time frame: Month 2, 4, 10
Number of patients with any adverse event
time frame: Month 2, 4, 10
Grade of Investigator's satisfaction
time frame: Month 2, 4, 10

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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)
Principal investigator CS You, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by Anterogen Co., Ltd..