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Safety and Efficacy Study of Autologous Cultured Adipose -Derived Stem Cells for the Crohn's Fistula

Primary Purpose

Crohn's Fistula

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ADIPOPLUS
Sponsored by
Anterogen Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Fistula

Eligibility Criteria

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

Inclusion Criteria:

  • Older than 18 years
  • Prior diagnosis of Crohn's disease
  • patients who have Crohn's fistula
  • negative for serum beta-HCG for woman of childbearing age
  • agreement to participate, with signed informed-consent

Exclusion Criteria:

  • patients who have allergy to bovine-derived materials or an anesthetic
  • patients with a diagnosis of auto immune disease except for Crohn's disease
  • Diagnosis of HBV, HCV, HIV and other infectious disease
  • Patients who have a symptom of septicemia
  • Patients with a diagnosis of active Tuberculosis
  • Patient who are pregnant or breast-feeding
  • Patients who are unwilling to use an "effective" method of contraception during the study
  • Patients with a diagnosis of Inflammatory Bowel Disease except for Crohn's disease
  • Patients who are sensitive to Fibrin glue
  • Patients who have a clinically relevant history of abuse of alcohol or drugs, habitual smoker
  • Insufficient adipose tissue for manufacturing of ADIPOPLUS
  • Patients who are considered not suitable for the study by investigator
  • Patients with a diagnosis of active refractory Crohn's disease
  • Patients who have history of surgery for malignant cancer in the past 5 years
  • Patients who have > 2 cm diameter of fistula

Sites / Locations

  • Asan medical center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ADIPOPLUS

Arm Description

patients with a fistula in Crohn's disease

Outcomes

Primary Outcome Measures

Efficacy: complete closure of fistula at week 8
number of patients with any adverse event

Secondary Outcome Measures

Photo of target fistula
taking Photo of target fistula : Day 0, week 4, 6, 8
number of patients with any adverse events
Adverse reaction : day 0, Week 4, 6, 8
number of patients with complete closure of fistula
complete closure : every visits more than 50% closure of fistula : every visits
Investigator's satisfaction
Investigator's satisfaction : week 8

Full Information

First Posted
November 10, 2009
Last Updated
March 14, 2012
Sponsor
Anterogen Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01011244
Brief Title
Safety and Efficacy Study of Autologous Cultured Adipose -Derived Stem Cells for the Crohn's Fistula
Official Title
A Phase II Clinical Study of ADIPOPLUS (Autologous Cultured Adipose-derived Stem Cell) for the Treatment of Crohn's Fistula to Evaluate Safety and Efficacy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (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
Up to date, a sure cure for Crohn's fistula does not known and the fistula recurrence rate is high. On 15 October 2008, orphan designation was granted by Korea FDA for human adipose-derived stem cell (ADIPOPLUS) for the treatment of Crohn's fistula. In this study, patients are given injection of ADIPOPLUS in fistula site and followed for 8 weeks to evaluate the safety and efficacy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Fistula

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ADIPOPLUS
Arm Type
Experimental
Arm Description
patients with a fistula in Crohn's disease
Intervention Type
Biological
Intervention Name(s)
ADIPOPLUS
Other Intervention Name(s)
ANTG-ASC
Intervention Description
autologous cultured adipose-derived stem cells 1x10e7 cells/1cm2 depending on surface area of fistula
Primary Outcome Measure Information:
Title
Efficacy: complete closure of fistula at week 8
Time Frame
8 weeks
Title
number of patients with any adverse event
Time Frame
Day 0, Week 8
Secondary Outcome Measure Information:
Title
Photo of target fistula
Description
taking Photo of target fistula : Day 0, week 4, 6, 8
Time Frame
8 weeks
Title
number of patients with any adverse events
Description
Adverse reaction : day 0, Week 4, 6, 8
Time Frame
8 weeks
Title
number of patients with complete closure of fistula
Description
complete closure : every visits more than 50% closure of fistula : every visits
Time Frame
8 weeks
Title
Investigator's satisfaction
Description
Investigator's satisfaction : week 8
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Older than 18 years Prior diagnosis of Crohn's disease patients who have Crohn's fistula negative for serum beta-HCG for woman of childbearing age agreement to participate, with signed informed-consent Exclusion Criteria: patients who have allergy to bovine-derived materials or an anesthetic patients with a diagnosis of auto immune disease except for Crohn's disease Diagnosis of HBV, HCV, HIV and other infectious disease Patients who have a symptom of septicemia Patients with a diagnosis of active Tuberculosis Patient who are pregnant or breast-feeding Patients who are unwilling to use an "effective" method of contraception during the study Patients with a diagnosis of Inflammatory Bowel Disease except for Crohn's disease Patients who are sensitive to Fibrin glue Patients who have a clinically relevant history of abuse of alcohol or drugs, habitual smoker Insufficient adipose tissue for manufacturing of ADIPOPLUS Patients who are considered not suitable for the study by investigator Patients with a diagnosis of active refractory Crohn's disease Patients who have history of surgery for malignant cancer in the past 5 years Patients who have > 2 cm diameter of fistula
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CS Yu, MD, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan medical center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy Study of Autologous Cultured Adipose -Derived Stem Cells for the Crohn's Fistula

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