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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01011244
First Posted: November 11, 2009
Last Update Posted: March 15, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Anterogen Co., Ltd.
  Purpose
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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01011244


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

Responsible Party: Anterogen Co., Ltd.
ClinicalTrials.gov Identifier: NCT01011244     History of Changes
Other Study ID Numbers: ANTG-ASC-202
First Submitted: November 10, 2009
First Posted: November 11, 2009
Last Update Posted: March 15, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Fistula
Pathological Conditions, Anatomical