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

This study has been completed.

Sponsor:

Information provided by:

Anterogen Co., Ltd.

ClinicalTrials.gov Identifier:

NCT00992485

First received: September 29, 2009

Last updated: May 7, 2010

Last verified: May 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	September 29, 2009
Last Updated Date	May 7, 2010
Start Date ^ICMJE	November 2008
Primary Completion Date	September 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 8, 2009)	Efficacy: closure of fistula at week 8 Safety: - Clinically measured abnormality of laboratory tests and adverse events [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00992485 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 8, 2009)	Closure of fistula [ Time Frame: week 4 ] Investigator satisfaction [ Time Frame: week 4 and week 8 ] Patient satisfaction [ Time Frame: week 4 and week 8 ] Digital photography [ Time Frame: day 1, week 4 and week 8 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy Study of Autologous Cultured Adipose -Derived Stem Cells for the Crohn's Fistula
Official Title ^ICMJE	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
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
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Crohn's Fistula
Intervention ^ICMJE	Drug: ADIPOPLUS autologous adipose-derived stem cell Other Name: ADIPOPLUS
Study Arm (s)	Experimental: autologous adipose derived stem cell Intervention: Drug: ADIPOPLUS
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	9
Completion Date	March 2010
Primary Completion Date	September 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT00992485
Other Study ID Numbers ^ICMJE	ANTG-ASC-201
Has Data Monitoring Committee	Not Provided
Responsible Party	Mihyung Kim, Director
Study Sponsor ^ICMJE	Anterogen Co., Ltd.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Anterogen Co., Ltd.
Verification Date	May 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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