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
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 April 23, 2014