Safety and Efficacy Study of Autologous Cultured Adipose -Derived Stem Cells for the Crohn's Fistula
NCT ID: NCT00992485
Last Updated: 2010-05-10
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
9 participants
INTERVENTIONAL
2008-11-30
2010-03-31
Brief Summary
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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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autologous adipose derived stem cell
ADIPOPLUS
autologous adipose-derived stem cell
Interventions
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ADIPOPLUS
autologous adipose-derived stem cell
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Anterogen Co., Ltd.
INDUSTRY
Responsible Party
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Director
Locations
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Asan medical center
Seoul, , South Korea
Countries
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Other Identifiers
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ANTG-ASC-201
Identifier Type: -
Identifier Source: org_study_id
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