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

Crohn's Fistula Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00992485
• Other study ID #: ANTG-ASC-201
• Status: Completed
• Phase: Phase 1
• First received: September 29, 2009
• Last updated: May 7, 2010
• Start date: November 2008
• Est. completion date: March 2010

Study information

• Verified date: May 2010
• Source: Anterogen Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: March 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn's Fistula
• Fistula

Intervention

Drug:
• ADIPOPLUS
autologous adipose-derived stem cell

Locations

Country	Name	City	State
Korea, Republic of	Asan medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Anterogen Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: closure of fistula at week 8 Safety: - Clinically measured abnormality of laboratory tests and adverse events			Yes
Secondary	Closure of fistula		week 4
Secondary	Investigator satisfaction		week 4 and week 8
Secondary	Patient satisfaction		week 4 and week 8
Secondary	Digital photography		day 1, week 4 and week 8