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

Phase 1

Completed

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

• Registration Number: NCT00992485
• Lead Sponsor: Anterogen Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2009-09
• Study First Submitted: 2009-09-29
• Study First Submitted QC: 2009-10-08
• Study First Posted: 2009-10-09
• Study Completion: 2010-03
• Status Verified: 2010-05
• Last Update Submitted: 2010-05-07
• Last Update Posted: 2010-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Older than 18 years
• Prior diagnosis of Crohn's disease
• patients who have Crohn's fistula
• negative for urine 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
• Patients 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 is sensitive to Fibrin glue
• Patients who have a clinically relevant history of abuse of alcohol or drugs
• Insufficient adipose tissue for manufacturing of ADIPOPLUS
• Patients who are considered not suitable for the study by investigator
• Patients who have history of surgery for malignant cancer in the past 5 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
autologous adipose derived stem cell	ADIPOPLUS	-

Primary Outcome Measures

Name	Time	Method
Efficacy: closure of fistula at week 8 Safety: - Clinically measured abnormality of laboratory tests and adverse events

Secondary Outcome Measures

Name	Time	Method
Investigator satisfaction	week 4 and week 8
Patient satisfaction	week 4 and week 8
Digital photography	day 1, week 4 and week 8
Closure of fistula	week 4

Trial Locations

Locations (1)

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