Study of Allogenic Adipose-derived Stem Cells in Crohn's Fistula (ALLO-ASC)

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. Identifier: NCT01440699
Recruitment Status : Unknown
Verified September 2011 by Anterogen Co., Ltd..
Recruitment status was:  Recruiting
First Posted : September 26, 2011
Last Update Posted : September 26, 2011
Information provided by (Responsible Party):
Anterogen Co., Ltd.

Brief Summary:

Adipose-derived stem cells have properties of differentiation to various types of cells, immunomodulatory effects. adipose-derived stem cells (ASCs) show also low immunogenicity.

Anterogen has developed ANTG-ASC(Autologous ASC) which has shown good efficacy and safety in Phase I and II study on the patients with Crohn's fistula.

However, Crohn's patients are sometimes not fat enough to extract fat tissue for culturing ASCs. Therefore the investigators have planned to study allogenic ASCs for safety and efficacy in patients with Crohn's fistula.

Condition or disease Intervention/treatment Phase
Crohn Biological: Allogenic human adipose-derived stem cells Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Dose Escalation of Human Allogenic Adipose-derived Stem Cells (ALLO-ASC) to Evaluate Safety and Efficacy in Patients With Crohn's Fistula
Study Start Date : September 2011
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Treatment
For ALLO-ASC 1xE7 cells/ml,3 patients are to be enrolled. If there is no safety issue, 3 more patients will be enrolled to be treated with ALLO-ASC 3xE7 cells/ml.
Biological: Allogenic human adipose-derived stem cells
ALLO-ASC 1xE7 cells/mL is injected once along the fistula. If there is no safety issue for 4 weeks, 3 more people could be enrolled who are subject to ALLO-ASC 3xE7 cells/mL.
Other Name: ALLO-ASC

Primary Outcome Measures :
  1. General safety (Laboratory screening, adverse effects, immunological response, local tolerance) [ Time Frame: Week8 ]

Secondary Outcome Measures :
  1. Proportion of patients with sustained efficacy [ Time Frame: Month 8 ]
    Proportion of patients with more than 50% healed fistula at Month 8 Following up whether there is a recurrence at Month 8

  2. Proportion of patients with adverse effects [ Time Frame: at month 8 ]
    Evaluate the safety at 8 months whether any kind of AE occurs.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosed with Crohn's disease
  • Crohn's fistula which has been lasted at least for 3 months
  • Negative for beta-HCG pregnancy test

Exclusion Criteria:

  • Medical history with Variant Creutzfeldt Jacobs Disease
  • Allergic to anesthetics or bovine protein or fibrin glue
  • autoimmune disease other than Crohn's disease
  • Infectious disease
  • Sepsis or active tuberculosis
  • pregnant or breast feeding woman
  • Inflammatory Bowel disease other than Crohn's disease
  • active crohn's disease with CDAI score > 200
  • malignant tumor
  • fistula's diameter > 2 cm

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 identifier (NCT number): NCT01440699

Korea, Republic of
Keonghee Medical Center Recruiting
Seoul, Korea, Republic of
Contact: HJ Kim, MD, PhD    82-2-958-9996      
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: KJ Park, MD, PhD    82-2-2072-2321      
Yeonsei Medical Center Recruiting
Seoul, Korea, Republic of
Contact: TI Kim, MD, PhD    82-2-2228-5170      
Sponsors and Collaborators
Anterogen Co., Ltd.
Principal Investigator: TI Kim, MD, PhD Yeonsei Medical Center

Responsible Party: Anterogen Co., Ltd. Identifier: NCT01440699     History of Changes
Other Study ID Numbers: ALLO-ASC-101
First Posted: September 26, 2011    Key Record Dates
Last Update Posted: September 26, 2011
Last Verified: September 2011

Keywords provided by Anterogen Co., Ltd.:
Crohn's fistula

Additional relevant MeSH terms:
Pathological Conditions, Anatomical