Follow-up Study of Autologous Adipose-derived Stem Cells (ANTG-ASC) for the Complex Fistula (ANTG-ASC-211)
NCT ID: NCT01623453
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
6 participants
OBSERVATIONAL
2010-09-30
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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PROSPECTIVE
Study Groups
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Low dose group
Group1. Low dose group
Autologous 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.
High dose group
Group2. High dose group
Autologous 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 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 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
* the patients with complete closure at week 8 after last injection in ANTG-ASC-210 trials
* the patients who submit written informed consents and is able to obey requirements of trials
Exclusion Criteria
* 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 a symptom of septicemia or active tuberculosis (contain tuberculosis of anus and rectum)
* a patient who is pregnant or breast feeding
* a patient who is not willing to use effective contraceptive methods during the study
* a patient who has inflammatory Bowel disease
* a patient who is sensitive to fibrin glue
* a patient who have a clinically relevant history of abuse of alcohol or drugs, habitual smoker (who smoked more than 20 cigarettes a day)
* a patient who is not able to understand the objective of this study or to comply with the study requirements
* a patient who is considered to have a significant disease which can impact the study by investigator
* a patient who is considered not suitable for the study by investigator
* a patient who had a history of surgery for malignant tumor within the last five years (except carcinoma in situ)
* a patient who has multisystemic wasting syndrome (such as tuberculosis, Diabetes, Thyroid disorders, tumor, etc.)
* a patient who has taken cytotoxic drugs (such as immunosuppressants, corticosteroid, cytotoxic chemotherapy, anticoagulants, etc.) during long-term
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
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
DS Kim
Role: PRINCIPAL_INVESTIGATOR
Daehang Hospital
Locations
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DaeHang Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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ANTG-ASC-211
Identifier Type: -
Identifier Source: org_study_id