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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 1
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 urine 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
  • Patients 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 is sensitive to Fibrin glue
  • Patients who have a clinically relevant history of abuse of alcohol or drugs
  • Insufficient adipose tissue for manufacturing of ADIPOPLUS
  • Patients who are considered not suitable for the study by investigator
  • Patients who have history of surgery for malignant cancer in the past 5 years

Sites / Locations

  • Asan medical center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

autologous adipose derived stem cell

Arm Description

Outcomes

Primary Outcome Measures

Efficacy: closure of fistula at week 8 Safety: - Clinically measured abnormality of laboratory tests and adverse events

Secondary Outcome Measures

Closure of fistula
Investigator satisfaction
Patient satisfaction
Digital photography

Full Information

First Posted
September 29, 2009
Last Updated
May 7, 2010
Sponsor
Anterogen Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00992485
Brief Title
Safety and Efficacy Study of Autologous Cultured Adipose -Derived Stem Cells for the Crohn's Fistula
Official Title
A Phase I Dose Escalation 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
May 2010
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Anterogen Co., Ltd.

4. Oversight

5. Study Description

Brief Summary
Up to date, a sure cure for Crohn's fistula has not known and the fistula recurrence rate is high. On 15 October 2008, orphan drug designation was granted by Korea FDA to Anterogen Co. Ltd., for human adipose-derived stem cell. In this study, patients are given injection of ADIPOPLUS in fistula site and followed for 8 weeks to test 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 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
autologous adipose derived stem cell
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ADIPOPLUS
Intervention Description
autologous adipose-derived stem cell
Primary Outcome Measure Information:
Title
Efficacy: closure of fistula at week 8 Safety: - Clinically measured abnormality of laboratory tests and adverse events
Secondary Outcome Measure Information:
Title
Closure of fistula
Time Frame
week 4
Title
Investigator satisfaction
Time Frame
week 4 and week 8
Title
Patient satisfaction
Time Frame
week 4 and week 8
Title
Digital photography
Time Frame
day 1, week 4 and week 8

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 urine 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 Patients 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 is sensitive to Fibrin glue Patients who have a clinically relevant history of abuse of alcohol or drugs Insufficient adipose tissue for manufacturing of ADIPOPLUS Patients who are considered not suitable for the study by investigator Patients who have history of surgery for malignant cancer in the past 5 years
Facility Information:
Facility Name
Asan medical center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

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

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