NCT00992485

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2009

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 9, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

May 10, 2010

Status Verified

May 1, 2010

Enrollment Period

10 months

First QC Date

September 29, 2009

Last Update Submit

May 7, 2010

Conditions

Crohn's Fistula

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

  • Closure of fistula

    week 4

  • Investigator satisfaction

    week 4 and week 8

  • Patient satisfaction

    week 4 and week 8

  • Digital photography

    day 1, week 4 and week 8

Study Arms (1)

autologous adipose derived stem cell

EXPERIMENTAL
Drug: ADIPOPLUS

Interventions

ADIPOPLUSDRUG

autologous adipose-derived stem cell

autologous adipose derived stem cell

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan medical center

Seoul, 138-736, South Korea

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 29, 2009

First Posted

October 9, 2009

Study Start

November 1, 2008

Primary Completion

September 1, 2009

Study Completion

March 1, 2010

Last Updated

May 10, 2010

Record last verified: 2010-05

Locations

KR(1)