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

Primary Purpose

Complex Perianal Fistula

Status
Terminated
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Autologous cultured adipose derived stem cells(low dose group)
Autologous cultured adipose derived stem cells(high dose group)
Sponsored by
Anterogen Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complex Perianal Fistula focused on measuring crohn's disease, fistula, complex

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Soon cheun Hyang university bucheon hospital
  • Ewha womwn university mokdong hospital
  • DaeHang Hospital
  • Samsung seoul Hospital
  • Seoul National University Hospital
  • Seoul Saint Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1

Group 2

Arm Description

Low dose group

high dose group

Outcomes

Primary Outcome Measures

Number of patients with complete closure of fistula (week 8)
Proportion of patients with completely closed fistula (week 8)

Secondary Outcome Measures

Grade of investigator's satisfaction
Grade of investigator's satisfaction (8 weeks after final dose) very satisfaction satisfaction somewhat satisfaction unsatisfaction very unsatisfaction
Number of patients with closed fistula
proportion of patients with completely closed fistula (every visits) proportion of patients with more than 50 % closed fistula (every visits)
Photo of target fistula
Taking picture of target fistula at Day 0 and Week 4, 6, 8
Number of patients with adverse events
Number of patients with any kinds of adverse events (Day 0, every visits)

Full Information

First Posted
March 8, 2011
Last Updated
November 21, 2016
Sponsor
Anterogen Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01314092
Brief Title
Clinical Trials of Autologous Cultured Adipose-derived Stem Cells (ANTG-ASC) on Complex Fistula
Acronym
ANTG-ASC-210
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 Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Terminated
Why Stopped
Difficulty recruiting subjects.
Study Start Date
January 2011 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anterogen Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Perianal Fistula
Keywords
crohn's disease, fistula, complex

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Low dose group
Arm Title
Group 2
Arm Type
Experimental
Arm Description
high dose group
Intervention Type
Biological
Intervention Name(s)
Autologous cultured adipose derived stem cells(low dose group)
Other Intervention Name(s)
mesenchymal stem cell, ANTG-ASC, adipose derived stem cell, Group1: low dose group
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Autologous cultured adipose derived stem cells(high dose group)
Other Intervention Name(s)
mesenchymal stem cell, ANTG-ASC, adipose derived stem cell, Group2: high dose group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of patients with complete closure of fistula (week 8)
Description
Proportion of patients with completely closed fistula (week 8)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Grade of investigator's satisfaction
Description
Grade of investigator's satisfaction (8 weeks after final dose) very satisfaction satisfaction somewhat satisfaction unsatisfaction very unsatisfaction
Time Frame
8 weeks
Title
Number of patients with closed fistula
Description
proportion of patients with completely closed fistula (every visits) proportion of patients with more than 50 % closed fistula (every visits)
Time Frame
8 weeks
Title
Photo of target fistula
Description
Taking picture of target fistula at Day 0 and Week 4, 6, 8
Time Frame
8 weeks
Title
Number of patients with adverse events
Description
Number of patients with any kinds of adverse events (Day 0, every visits)
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KJ Park, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
DS Kim
Organizational Affiliation
Daehang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soon cheun Hyang university bucheon hospital
City
Bucheon-si
ZIP/Postal Code
420-767
Country
Korea, Republic of
Facility Name
Ewha womwn university mokdong hospital
City
Seoul
ZIP/Postal Code
158-710
Country
Korea, Republic of
Facility Name
DaeHang Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung seoul Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Saint Mary's Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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