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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:
Information provided by:
Anterogen Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00992485
First received: September 29, 2009
Last updated: May 7, 2010
Last verified: May 2010
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 [ Designated as safety issue: Yes ]

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
Other Name: ADIPOPLUS

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00992485

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

No publications provided

Responsible Party: Mihyung Kim, Director
ClinicalTrials.gov Identifier: NCT00992485     History of Changes
Other Study ID Numbers: ANTG-ASC-201
Study First Received: September 29, 2009
Last Updated: May 7, 2010
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Fistula
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on November 20, 2014