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

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

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.

Study Overview

• Status: Completed
• Conditions: Crohn's Fistula
• Intervention / Treatment: Drug: ADIPOPLUS

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 138-736
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: autologous adipose derived stem cell	Drug: ADIPOPLUS; autologous adipose-derived stem cell

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Anterogen Co., Ltd.

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: September 29, 2009
• First Submitted That Met QC Criteria: October 8, 2009
• First Posted (Estimate): October 9, 2009

Study Record Updates

• Last Update Posted (Estimate): May 10, 2010
• Last Update Submitted That Met QC Criteria: May 7, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Fistula
• Other Study ID Numbers: ANTG-ASC-201