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

Crohn's Fistula Clinical Trial

Official title:

A Phase II Clinical Study of ADIPOPLUS (Autologous Cultured Adipose-derived Stem Cell) for the Treatment of Crohn's Fistula to Evaluate Safety and Efficacy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01011244
• Other study ID #: ANTG-ASC-202
• Status: Completed
• Phase: Phase 2
• First received: November 10, 2009
• Last updated: March 14, 2012
• Start date: February 2010
• Est. completion date: September 2011

Study information

• Verified date: March 2012
• Source: Anterogen Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn's Fistula
• Fistula

Intervention

Biological:
• ADIPOPLUS
autologous cultured adipose-derived stem cells 1x10e7 cells/1cm2 depending on surface area of fistula

Locations

Country	Name	City	State
Korea, Republic of	Asan medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Anterogen Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: complete closure of fistula at week 8		8 weeks	No
Primary	number of patients with any adverse event		Day 0, Week 8	Yes
Secondary	Photo of target fistula	taking Photo of target fistula : Day 0, week 4, 6, 8	8 weeks	No
Secondary	number of patients with any adverse events	Adverse reaction : day 0, Week 4, 6, 8	8 weeks	Yes
Secondary	number of patients with complete closure of fistula	complete closure : every visits more than 50% closure of fistula : every visits	8 weeks	No
Secondary	Investigator's satisfaction	Investigator's satisfaction : week 8	8 weeks	No