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

NCT ID: NCT01011244

Last Updated: 2012-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2011-09-30

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.

Conditions

Crohn's Fistula

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ADIPOPLUS

patients with a fistula in Crohn's disease

Group Type: EXPERIMENTAL

ADIPOPLUS

Intervention Type: BIOLOGICAL

autologous cultured adipose-derived stem cells

1x10e7 cells/1cm2 depending on surface area of fistula

Interventions

ADIPOPLUS

autologous cultured adipose-derived stem cells

1x10e7 cells/1cm2 depending on surface area of fistula

Intervention Type: BIOLOGICAL

Other Intervention Names

ANTG-ASC

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anterogen Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

CS Yu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan medical center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

ANTG-ASC-202

Identifier Type: -

Identifier Source: org_study_id