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

NCT01011244 | Completed Phase 2 DMC

• 1 other identifier: ANTG-ASC-202
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Efficacy: complete closure of fistula at week 8

  8 weeks

• number of patients with any adverse event

  Day 0, Week 8

Secondary Outcomes (4)

• Photo of target fistula

  8 weeks

• number of patients with any adverse events

  8 weeks

• number of patients with complete closure of fistula

  8 weeks

• Investigator's satisfaction

  8 weeks

Study Arms (1)

ADIPOPLUS

EXPERIMENTAL

patients with a fistula in Crohn's disease

Biological: ADIPOPLUS

Interventions

ADIPOPLUS BIOLOGICAL

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

Also known as: ANTG-ASC

ADIPOPLUS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anterogen Co., Ltd.: lead

Study Sites (1)

Asan medical center

Seoul, 138-736, South Korea

Location

Study Officials

• CS Yu, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2009
• First Posted: November 11, 2009
• Study Start: February 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: March 15, 2012

Record last verified: 2012-03

Locations

KR (1)