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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00992485
First Posted: October 9, 2009
Last Update Posted: May 10, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Anterogen Co., Ltd.
  Purpose
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.

Condition Intervention Phase
Crohn's Fistula Drug: ADIPOPLUS Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Anterogen Co., Ltd.:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 9
Study Start Date: November 2008
Study Completion Date: March 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: autologous adipose derived stem cell Drug: ADIPOPLUS
autologous adipose-derived stem cell

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00992485


Locations
Korea, Republic of
Asan medical center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Anterogen Co., Ltd.
  More Information

Responsible Party: Mihyung Kim, Director
ClinicalTrials.gov Identifier: NCT00992485     History of Changes
Other Study ID Numbers: ANTG-ASC-201
First Submitted: September 29, 2009
First Posted: October 9, 2009
Last Update Posted: May 10, 2010
Last Verified: May 2010

Additional relevant MeSH terms:
Fistula
Pathological Conditions, Anatomical