Follow-up Study of Autologous Cultured Adipose-derived Stem Cells for the Crohn's Fistula

Completed

• Conditions: Fistula; Crohn's Disease

• Registration Number: NCT01314079
• Lead Sponsor: Anterogen Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2011-03-08
• Study First Submitted QC: 2011-03-11
• Study First Posted: 2011-03-14
• Status Verified: 2012-03
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Last Update Submitted: 2016-11-21
• Last Update Posted: 2016-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with Sustained efficacy of complete closure of fistula	Month 4, 10	Proportion of patients whose fistula has been completely closed.

Secondary Outcome Measures

Name	Time	Method
Number of patients with sustained efficacy of closure of fistula	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	Month 2, 4, 10	number of patients with any adverse event (Month 2, 4, 10)
Grade of Investigator's satisfaction	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

Trial Locations

Locations (3)

DaeHang Hospital; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Seoul Asan Hospital; 🇰🇷 Seoul, Korea, Republic of