This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by (Responsible Party):
Anterogen Co., Ltd. Identifier:
First received: November 10, 2009
Last updated: March 14, 2012
Last verified: March 2012
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.

Condition Intervention Phase
Crohn's Fistula Biological: ADIPOPLUS Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Anterogen Co., Ltd.:

Primary Outcome Measures:
  • Efficacy: complete closure of fistula at week 8 [ Time Frame: 8 weeks ]
  • number of patients with any adverse event [ Time Frame: Day 0, Week 8 ]

Secondary Outcome Measures:
  • Photo of target fistula [ Time Frame: 8 weeks ]
    taking Photo of target fistula : Day 0, week 4, 6, 8

  • number of patients with any adverse events [ Time Frame: 8 weeks ]
    Adverse reaction : day 0, Week 4, 6, 8

  • number of patients with complete closure of fistula [ Time Frame: 8 weeks ]
    complete closure : every visits more than 50% closure of fistula : every visits

  • Investigator's satisfaction [ Time Frame: 8 weeks ]
    Investigator's satisfaction : week 8

Estimated Enrollment: 40
Study Start Date: February 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ADIPOPLUS
patients with a fistula in Crohn's disease
Biological: ADIPOPLUS

autologous cultured adipose-derived stem cells

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

Other Name: ANTG-ASC


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01011244

Korea, Republic of
Asan medical center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Anterogen Co., Ltd.
Principal Investigator: CS Yu, MD, PhD Asan Medical Center
  More Information

Responsible Party: Anterogen Co., Ltd. Identifier: NCT01011244     History of Changes
Other Study ID Numbers: ANTG-ASC-202
Study First Received: November 10, 2009
Last Updated: March 14, 2012

Additional relevant MeSH terms:
Pathological Conditions, Anatomical processed this record on August 21, 2017