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

Anterogen

Status and phase

Completed

Phase 2

Conditions

Crohn's Fistula

Treatments

Biological: ADIPOPLUS

Study type

Interventional

Funder types

Industry

Identifiers

NCT01011244

ANTG-ASC-202

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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