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Completed

NCT Number: NCT01011244

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

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.

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Key information

Conditions

Crohn's Fistula

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Asan medical center

Seoul, 138-736, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ADIPOPLUS

Biological

autologous cultured adipose-derived stem cells

1x10e7 cells/1cm2 depending on surface area of fistula

Other names: ANTG-ASC

Primary outcomes

  1. Efficacy: complete closure of fistula at week 8

    Time frame: 8 weeks

  2. number of patients with any adverse event

    Time frame: Day 0, Week 8

Secondary outcomes

  1. Photo of target fistula

    Time frame: 8 weeks

    taking Photo of target fistula : Day 0, week 4, 6, 8

  2. number of patients with any adverse events

    Time frame: 8 weeks

    Adverse reaction : day 0, Week 4, 6, 8

  3. number of patients with complete closure of fistula

    Time frame: 8 weeks

    complete closure : every visits more than 50% closure of fistula : every visits

  4. Investigator's satisfaction

    Time frame: 8 weeks

    Investigator's satisfaction : week 8

Sponsors and collaborators

Lead sponsor

Anterogen Co., Ltd.

Industry

Registry information

Official study title

A Phase II Clinical Study of ADIPOPLUS (Autologous Cultured Adipose-derived Stem Cell) for the Treatment of Crohn's Fistula to Evaluate Safety and Efficacy

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 11, 2009
Registry last updated
Mar 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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