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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Anterogen Co., Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Anterogen Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01314092
First received: March 8, 2011
Last updated: March 28, 2011
Last verified: March 2011
History of Changes
  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
 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:

U.S. FDA Resources

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)


Estimated Enrollment: 40
Study Start Date: January 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (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: 1x10e7 cells/mL, 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 Name: mesenchymal stem cell, ANTG-ASC, adipose derived stem cell
Experimental: Group 2
high dose group
 Biological: Autologous cultured adipose derived stem cells
low dose group: 1x10e7 cells/mL, 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 Name: mesenchymal stem cell, ANTG-ASC, adipose derived stem cell

  Eligibility

Ages Eligible for Study:   18 Years and older
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01314092

Contacts
Contact: KJ Park, MD, PhD 82-2-2072-2901
Contact: DS Kim, MD, PhD 82-2-6388-8114

Locations
Korea, Republic of
Seoul Asan Hospital Recruiting
Seoul, Korea, Republic of
Contact: CS You, MD, PhD            
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: KJ Park, MD, PhD            
DaeHang Hospital Recruiting
Seoul, Korea, Republic of
Contact: DS Kim, MD, PhD            
Samsung seoul Hospital Recruiting
Seoul, Korea, Republic of
Contact: WY Lee            
Seoul Saint Mary's Hospital Recruiting
Seoul, Korea, Republic of
Contact: ST Oh, MD, PhD            
Sponsors and Collaborators
Anterogen Co., Ltd.
Investigators
Principal Investigator: CS You, MD, PhD Asan Medical Center
  More Information

No publications provided

Responsible Party: Mihyung Kim, Director, Anterogen
ClinicalTrials.gov Identifier: NCT01314092     History of Changes
Other Study ID Numbers: ANTG-ASC-210
Study First Received: March 8, 2011
Last Updated: March 28, 2011
Health Authority: Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Fistula
Rectal Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
 Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 19, 2013