Clinical Trials of Autologous Cultured Adipose-derived Stem Cells (ANTG-ASC) on Complex Fistula
NCT ID: NCT01314092
Last Updated: 2016-11-23
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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TERMINATED
PHASE2
15 participants
INTERVENTIONAL
2011-01-31
2014-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group 1
Low dose group
Autologous cultured adipose derived stem cells(low dose group)
low dose group: 1x10e7 cells/mL At 6 weeks after first stem cell injection, fistula closing was assessed. If it is not completely closed, second injection would be applied in 2 weeks. Additional dosage would be doubled to first dosage.
Group 2
high dose group
Autologous cultured adipose derived stem cells(high dose group)
high dose group: 2x10e7 cells/mL At 6 weeks after first stem cell injection, fistula closing was assessed. If it is not completely closed, second injection would be applied in 2 weeks. Additional dosage would be doubled to first dosage.
Interventions
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Autologous cultured adipose derived stem cells(low dose group)
low dose group: 1x10e7 cells/mL At 6 weeks after first stem cell injection, fistula closing was assessed. If it is not completely closed, second injection would be applied in 2 weeks. Additional dosage would be doubled to first dosage.
Autologous cultured adipose derived stem cells(high dose group)
high dose group: 2x10e7 cells/mL At 6 weeks after first stem cell injection, fistula closing was assessed. If it is not completely closed, second injection would be applied in 2 weeks. Additional dosage would be doubled to first dosage.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* a patient who is negative in pregnancy test
* a patient who has submitted a written consent
Exclusion Criteria
* a patient who has a history of variant Creutzfeldt Jacobs disease or related diseases
* a patient who is allergic to anesthetics, bovine derived proteins or a fibrin glue
* a patient who has an autoimmune disease
* a patient who has infectious diseases such as hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
* a patient who has sepsis or active tuberculosis
* a patient who is pregnant or breast feeding
* a patient who has inflammatory Bowel disease
* over 2cm in diameter of fistula
18 Years
ALL
No
Sponsors
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Anterogen Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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KJ Park, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
DS Kim
Role: PRINCIPAL_INVESTIGATOR
Daehang Hospital
Locations
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Soon cheun Hyang university bucheon hospital
Bucheon-si, , South Korea
Ewha womwn university mokdong hospital
Seoul, , South Korea
DaeHang Hospital
Seoul, , South Korea
Samsung seoul Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Seoul Saint Mary's Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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ANTG-ASC-210
Identifier Type: -
Identifier Source: org_study_id