Safety and Efficacy Study of Autologous Cultured Adipose... | NCT01011244

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

NCT01011244

Sponsor

Anterogen Co., Ltd.

Status

Completed

Last Update Posted

Mar 15, 2012Estimated

Enrollment

40Estimated

Phase

Phase 2

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

Mar 2012

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

Feb 2010

Primary Completion Date

Sep 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Nov 10, 2009

First Submission Date that Met QC Criteria

Nov 10, 2009

First Posted Date

Nov 11, 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

Mar 14, 2012

Last Update Posted Date

Mar 15, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ADIPOPLUS	Experimental	patients with a fistula in Crohn's disease	Biological: ADIPOPLUS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ADIPOPLUS	Biological	autologous cultured adipose-derived stem cells 1x10e7 cells/1cm2 depending on surface area of fistula	ADIPOPLUS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy: complete closure of fistula at week 8		8 weeks
number of patients with any adverse event		Day 0, Week 8

Secondary Outcomes

Measure	Description	Time Frame
Photo of target fistula	taking Photo of target fistula : Day 0, week 4, 6, 8	8 weeks
number of patients with any adverse events	Adverse reaction : day 0, Week 4, 6, 8

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 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

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