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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anterogen Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01011244
First received: November 10, 2009
Last updated: March 14, 2012
Last verified: March 2012
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • number of patients with any adverse event [ Time Frame: Day 0, Week 8 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Photo of target fistula [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    taking Photo of target fistula : Day 0, week 4, 6, 8

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

  • number of patients with complete closure of fistula [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    complete closure : every visits more than 50% closure of fistula : every visits

  • Investigator's satisfaction [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Anterogen Co., Ltd.
ClinicalTrials.gov Identifier: NCT01011244     History of Changes
Other Study ID Numbers: ANTG-ASC-202
Study First Received: November 10, 2009
Last Updated: March 14, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Crohn Disease
Fistula
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 22, 2014