Clinical Trials of Autologous Cultured Adipose-derived Stem Cells (ANTG-ASC) on Complex Fistula

Phase 2

Terminated

• Conditions: Complex Perianal Fistula
• Interventions: Biological: Autologous cultured adipose derived stem cells(high dose group); Biological: Autologous cultured adipose derived stem cells(low dose group)

• Registration Number: NCT01314092
• Lead Sponsor: Anterogen Co., Ltd.

Brief Summary

Mesenchymal stem cells derived from adipose tissue are pluripotent to differentiate into myocytes, adipocytes or others. They have an immunosuppressive activity. Complex perianal fistula is difficult to cure and easy to relapse. Autologous adipose stem cells have shown efficacy and safety on Crohn's fistula in phase 1 study. Based on these results, the investigators would apply autologous adipose stem cells on complex perianal fistula to evaluate their efficacy and safety.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Status Verified: 2011-03
• Study First Submitted: 2011-03-08
• Study First Submitted QC: 2011-03-11
• Study First Posted: 2011-03-14
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Last Update Submitted: 2016-11-21
• Last Update Posted: 2016-11-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• a patient who has complex perianal fistula
• a patient who is negative in pregnancy test
• a patient who has submitted a written consent

Exclusion Criteria

• a patient who has participated in other clinical studies within 30 days before this clinical trial or has not passed 5 fold period of a half-life of other investigational drugs.
• a patient who has a history of variant Creutzfeldt Jacobs disease or related diseases
• a patient who is allergic to anesthetics, bovine derived proteins or a fibrin glue
• a patient who has an autoimmune disease
• a patient who has infectious diseases such as hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
• a patient who has sepsis or active tuberculosis
• a patient who is pregnant or breast feeding
• a patient who has inflammatory Bowel disease
• over 2cm in diameter of fistula

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Autologous cultured adipose derived stem cells(high dose group)	high dose group
Group 1	Autologous cultured adipose derived stem cells(low dose group)	Low dose group

Primary Outcome Measures

Name	Time	Method
Number of patients with complete closure of fistula (week 8)	8 weeks	Proportion of patients with completely closed fistula (week 8)

Secondary Outcome Measures

Name	Time	Method
Grade of investigator's satisfaction	8 weeks	Grade of investigator's satisfaction (8 weeks after final dose); 1. very satisfaction; 2. satisfaction; 3. somewhat satisfaction; 4. unsatisfaction; 5. very unsatisfaction
Number of patients with closed fistula	8 weeks	* proportion of patients with completely closed fistula (every visits); * proportion of patients with more than 50 % closed fistula (every visits)
Photo of target fistula	8 weeks	Taking picture of target fistula at Day 0 and Week 4, 6, 8
Number of patients with adverse events	8 weeks	Number of patients with any kinds of adverse events (Day 0, every visits)

Trial Locations

Locations (6)

Soon cheun Hyang university bucheon hospital; 🇰🇷 Bucheon-si, Korea, Republic of

Ewha womwn university mokdong hospital; 🇰🇷 Seoul, Korea, Republic of

DaeHang Hospital; 🇰🇷 Seoul, Korea, Republic of

Samsung seoul Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul Saint Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of