Study of Allogenic Adipose-derived Stem Cells in Crohn's Fistula
NCT ID: NCT01440699
Last Updated: 2023-08-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
6 participants
INTERVENTIONAL
2011-09-30
2012-11-08
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Crohn's fistula which has been lasted at least for 3 months
* Negative for beta-HCG pregnancy test
Exclusion Criteria
* 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
18 Years
60 Years
ALL
No
Sponsors
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Anterogen Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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TI Kim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Yeonsei Medical Center
Locations
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Keonghee Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Yeonsei Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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ALLO-ASC-101
Identifier Type: -
Identifier Source: org_study_id
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