Safety and Efficacy Study of Autologous Cultured Adipose... | NCT00992485

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

NCT00992485

Sponsor

Anterogen Co., Ltd.

Status

Completed

Last Update Posted

May 10, 2010Estimated

Enrollment

9Actual

Phase

Phase 1

Conditions

Crohn's Fistula

Interventions

ADIPOPLUS

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Sep 2009Actual

Completion Date

Mar 2010Actual

First Submitted Date

Sep 29, 2009

First Submission Date that Met QC Criteria

Oct 8, 2009

First Posted Date

Oct 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 7, 2010

Last Update Posted Date

May 10, 2010Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
autologous adipose derived stem cell	Experimental		Drug: ADIPOPLUS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ADIPOPLUS	Drug	autologous adipose-derived stem cell	autologous adipose derived stem cell

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Closure of fistula		week 4
Investigator satisfaction		week 4 and week 8
Patient satisfaction

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided