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Clinical Trials of Autologous Cultured Adipose-derived Stem Cells (ANTG-ASC) on Complex Fistula (ANTG-ASC-210)

This study has been terminated.
(Difficulty recruiting subjects.)
Sponsor:
Information provided by (Responsible Party):
Anterogen Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01314092
First received: March 8, 2011
Last updated: November 21, 2016
Last verified: March 2011
  Purpose
Mesenchymal stem cells derived from adipose tissue are pluripotent to differentiate into myocytes, adipocytes or others. They have an immunosuppressive activity. Complex perianal fistula is difficult to cure and easy to relapse. Autologous adipose stem cells have shown efficacy and safety on Crohn's fistula in phase 1 study. Based on these results, the investigators would apply autologous adipose stem cells on complex perianal fistula to evaluate their efficacy and safety.

Condition Intervention Phase
Complex Perianal Fistula
Biological: Autologous cultured adipose derived stem cells(low dose group)
Biological: Autologous cultured adipose derived stem cells(high dose group)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Phase II Study to Evaluate Efficacy and Safety of ANTG-ASC (Autologous Cultured Adipose-derived Stem Cells) on the Complex Fistula Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of patients with complete closure of fistula (week 8) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Proportion of patients with completely closed fistula (week 8)


Secondary Outcome Measures:
  • Grade of investigator's satisfaction [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

    Grade of investigator's satisfaction (8 weeks after final dose)

    1. very satisfaction
    2. satisfaction
    3. somewhat satisfaction
    4. unsatisfaction
    5. very unsatisfaction

  • Number of patients with closed fistula [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    • proportion of patients with completely closed fistula (every visits)
    • proportion of patients with more than 50 % closed fistula (every visits)

  • Photo of target fistula [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Taking picture of target fistula at Day 0 and Week 4, 6, 8

  • Number of patients with adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    Number of patients with any kinds of adverse events (Day 0, every visits)


Enrollment: 15
Study Start Date: January 2011
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Low dose group
Biological: Autologous cultured adipose derived stem cells(low dose group)
low dose group: 1x10e7 cells/mL At 6 weeks after first stem cell injection, fistula closing was assessed. If it is not completely closed, second injection would be applied in 2 weeks. Additional dosage would be doubled to first dosage.
Other Names:
  • mesenchymal stem cell, ANTG-ASC, adipose derived stem cell
  • Group1: low dose group
Experimental: Group 2
high dose group
Biological: Autologous cultured adipose derived stem cells(high dose group)
high dose group: 2x10e7 cells/mL At 6 weeks after first stem cell injection, fistula closing was assessed. If it is not completely closed, second injection would be applied in 2 weeks. Additional dosage would be doubled to first dosage.
Other Names:
  • mesenchymal stem cell, ANTG-ASC, adipose derived stem cell
  • Group2: high dose group

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • a patient who has complex perianal fistula
  • a patient who is negative in pregnancy test
  • a patient who has submitted a written consent

Exclusion Criteria:

  • a patient who has participated in other clinical studies within 30 days before this clinical trial or has not passed 5 fold period of a half-life of other investigational drugs.
  • a patient who has a history of variant Creutzfeldt Jacobs disease or related diseases
  • a patient who is allergic to anesthetics, bovine derived proteins or a fibrin glue
  • a patient who has an autoimmune disease
  • a patient who has infectious diseases such as hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
  • a patient who has sepsis or active tuberculosis
  • a patient who is pregnant or breast feeding
  • a patient who has inflammatory Bowel disease
  • over 2cm in 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: NCT01314092

Locations
Korea, Republic of
Soon cheun Hyang university bucheon hospital
Bucheon-si, Korea, Republic of, 420-767
Ewha womwn university mokdong hospital
Seoul, Korea, Republic of, 158-710
DaeHang Hospital
Seoul, Korea, Republic of
Samsung seoul Hospital
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Seoul Saint Mary's Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Anterogen Co., Ltd.
Investigators
Principal Investigator: KJ Park, MD, PhD Seoul National University Hospital
Principal Investigator: DS Kim Daehang Hospital
  More Information

Responsible Party: Anterogen Co., Ltd.
ClinicalTrials.gov Identifier: NCT01314092     History of Changes
Other Study ID Numbers: ANTG-ASC-210 
Study First Received: March 8, 2011
Last Updated: November 21, 2016
Health Authority: Korea: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Anterogen Co., Ltd.:
crohn's disease
fistula
complex

Additional relevant MeSH terms:
Fistula
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on December 08, 2016