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

November 21, 2016 updated by: Anterogen Co., Ltd.

Phase II Study to Evaluate Efficacy and Safety of ANTG-ASC (Autologous Cultured Adipose-derived Stem Cells) on the Complex Fistula Patients

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Bucheon-si, Korea, Republic of, 420-767
        • Soon cheun Hyang university bucheon hospital
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • DaeHang Hospital
      • Seoul, Korea, Republic of
        • Seoul Saint Mary's Hospital
      • Seoul, Korea, Republic of
        • Samsung Seoul Hospital
      • Seoul, Korea, Republic of, 158-710
        • Ewha womwn university mokdong hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with complete closure of fistula (week 8)
Time Frame: 8 weeks
Proportion of patients with completely closed fistula (week 8)
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grade of investigator's satisfaction
Time Frame: 8 weeks

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

  1. very satisfaction
  2. satisfaction
  3. somewhat satisfaction
  4. unsatisfaction
  5. very unsatisfaction
8 weeks
Number of patients with closed fistula
Time Frame: 8 weeks
  • proportion of patients with completely closed fistula (every visits)
  • proportion of patients with more than 50 % closed fistula (every visits)
8 weeks
Photo of target fistula
Time Frame: 8 weeks
Taking picture of target fistula at Day 0 and Week 4, 6, 8
8 weeks
Number of patients with adverse events
Time Frame: 8 weeks
Number of patients with any kinds of adverse events (Day 0, every visits)
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anterogen Co., Ltd.

Investigators

  • Principal Investigator: KJ Park, MD, PhD, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

March 8, 2011

First Submitted That Met QC Criteria

March 11, 2011

First Posted (Estimate)

March 14, 2011

Study Record Updates

Last Update Posted (Estimate)

November 23, 2016

Last Update Submitted That Met QC Criteria

November 21, 2016

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANTG-ASC-210

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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