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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00992485

Enrollment

Registered

2009-10-09

Start date

2008-11-30

Completion date

2010-03-31

Last updated

2010-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Fistula

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.

Interventions

DRUGADIPOPLUS

autologous adipose-derived stem cell

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026