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

Sponsor
Anterogen Co., Ltd. (Industry)
Overall Status
Terminated
CT.gov ID
NCT01314092
Collaborator
(none)
15
Enrollment
6
Locations
2
Arms
44
Duration (Months)
2.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Biological: Autologous cultured adipose derived stem cells(low dose group)
  • Biological: Autologous cultured adipose derived stem cells(high dose group)
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
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
Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Sep 1, 2014
Actual Study Completion Date :
Sep 1, 2014

Arms and Interventions

Arm Intervention/Treatment
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients with complete closure of fistula (week 8) [8 weeks]

      Proportion of patients with completely closed fistula (week 8)

    Secondary Outcome Measures

    1. Grade of investigator's satisfaction [8 weeks]

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

    2. Number of patients with closed fistula [8 weeks]

      proportion of patients with completely closed fistula (every visits) proportion of patients with more than 50 % closed fistula (every visits)

    3. Photo of target fistula [8 weeks]

      Taking picture of target fistula at Day 0 and Week 4, 6, 8

    4. Number of patients with adverse events [8 weeks]

      Number of patients with any kinds of adverse events (Day 0, every visits)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Soon cheun Hyang university bucheon hospital Bucheon-si Korea, Republic of 420-767
    2 Ewha womwn university mokdong hospital Seoul Korea, Republic of 158-710
    3 DaeHang Hospital Seoul Korea, Republic of
    4 Samsung seoul Hospital Seoul Korea, Republic of
    5 Seoul National University Hospital Seoul Korea, Republic of
    6 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Anterogen Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT01314092
    Other Study ID Numbers:
    • ANTG-ASC-210
    First Posted:
    Mar 14, 2011
    Last Update Posted:
    Nov 23, 2016
    Last Verified:
    Mar 1, 2011
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Anterogen Co., Ltd.
    crohn's disease
    fistula
    complex
    Additional relevant MeSH terms:
    Fistula

    Study Results

    No Results Posted as of Nov 23, 2016