Safety and Efficacy Study of Autologous Cultured Adipose -Derived Stem Cells for the Crohn's Fistula

Phase 2

Completed

• Conditions: Crohn's Fistula
• Interventions: Biological: ADIPOPLUS

• Registration Number: NCT01011244
• Lead Sponsor: Anterogen Co., Ltd.

Brief Summary

Up to date, a sure cure for Crohn's fistula does not known and the fistula recurrence rate is high. On 15 October 2008, orphan designation was granted by Korea FDA for human adipose-derived stem cell (ADIPOPLUS) for the treatment of Crohn's fistula. In this study, patients are given injection of ADIPOPLUS in fistula site and followed for 8 weeks to evaluate the safety and efficacy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-11-10
• Study First Submitted QC: 2009-11-10
• Study First Posted: 2009-11-11
• Study Start: 2010-02
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-14
• Last Update Posted: 2012-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Older than 18 years
• Prior diagnosis of Crohn's disease
• patients who have Crohn's fistula
• negative for serum beta-HCG for woman of childbearing age
• agreement to participate, with signed informed-consent

Exclusion Criteria

• patients who have allergy to bovine-derived materials or an anesthetic
• patients with a diagnosis of auto immune disease except for Crohn's disease
• Diagnosis of HBV, HCV, HIV and other infectious disease
• Patients who have a symptom of septicemia
• Patients with a diagnosis of active Tuberculosis
• Patient who are pregnant or breast-feeding
• Patients who are unwilling to use an "effective" method of contraception during the study
• Patients with a diagnosis of Inflammatory Bowel Disease except for Crohn's disease
• Patients who are sensitive to Fibrin glue
• Patients who have a clinically relevant history of abuse of alcohol or drugs, habitual smoker
• Insufficient adipose tissue for manufacturing of ADIPOPLUS
• Patients who are considered not suitable for the study by investigator
• Patients with a diagnosis of active refractory Crohn's disease
• Patients who have history of surgery for malignant cancer in the past 5 years
• Patients who have > 2 cm diameter of fistula

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ADIPOPLUS	ADIPOPLUS	patients with a fistula in Crohn's disease

Primary Outcome Measures

Name	Time	Method
Efficacy: complete closure of fistula at week 8	8 weeks
number of patients with any adverse event	Day 0, Week 8

Secondary Outcome Measures

Name	Time	Method
Photo of target fistula	8 weeks	taking Photo of target fistula : Day 0, week 4, 6, 8
number of patients with any adverse events	8 weeks	Adverse reaction : day 0, Week 4, 6, 8
number of patients with complete closure of fistula	8 weeks	complete closure : every visits more than 50% closure of fistula : every visits
Investigator's satisfaction	8 weeks	Investigator's satisfaction : week 8

Trial Locations

Locations (1)

Asan medical center; 🇰🇷 Seoul, Korea, Republic of