- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01623453
Follow-up Study of Autologous Adipose-derived Stem Cells (ANTG-ASC) for the Complex Fistula (ANTG-ASC-211) (ANTG)
November 21, 2016 updated by: Anterogen Co., Ltd.
A Follow-up Study to Evaluate the Sustained Healing Effect the Patients Who Showed Complete Closure of Fistula the Previous ANTG-ASC-210 Study
This is an open follow-up clinical trial to evaluate a sustained efficacy and safety of ANTG-ASC injection for 4 months (6 months after final dose injection) after Phase II clinical trial.
Study Overview
Status
Terminated
Conditions
Study Type
Observational
Enrollment (Actual)
6
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Seoul, Korea, Republic of
- Seoul National University Hospital
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Seoul, Korea, Republic of
- DaeHang Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
• the patients with complete closure at week 8 after last injection in ANTG-ASC-210 trials
Description
Inclusion Criteria:
- the patients who have participated in ANTG-ASC-210 clinical trial
- 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 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 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Low dose group
Group1. Low dose group
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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.
Other Names:
|
High dose group
Group2. High dose group
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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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients with Sustained efficacy of complete closure of fistula
Time Frame: Month 4
|
Proportion of patients with completely closed of fistula (Month 4)
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Month 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients with sustained efficacy of closure of fistula
Time Frame: Month 2, 4
|
Proportion of patients with completely closed of fistula (Month 2) Proportion of patients with more than 50% closed of fistula (Month 2, 4) |
Month 2, 4
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Evaluation of Fecal Incontinence Score
Time Frame: Month 4
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Evaluation of Fecal Incontinence Score (Wexner Score, Cleveland Clinic Continence Scoring System)
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Month 4
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Grade of Investigator's satisfaction
Time Frame: Month 2, 4
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Grade of Investigator's satisfaction (Month 2, 4)
|
Month 2, 4
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Number of patients with adverse events as a measure of systemic tolerance and physical examinations
Time Frame: Month 2, 4
|
|
Month 2, 4
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: KJ Park, Seoul National University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (ACTUAL)
September 1, 2014
Study Completion (ACTUAL)
September 1, 2014
Study Registration Dates
First Submitted
June 8, 2012
First Submitted That Met QC Criteria
June 17, 2012
First Posted (ESTIMATE)
June 20, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
November 23, 2016
Last Update Submitted That Met QC Criteria
November 21, 2016
Last Verified
June 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ANTG-ASC-211
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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