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Difficulty recruiting subjects
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose group | Group1. Low dose group |
| |
| High dose group | Group2. High dose group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous adipose derived stem cells(low dose group) | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with Sustained efficacy of complete closure of fistula | Proportion of patients with completely closed of fistula (Month 4) | Month 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with sustained efficacy of closure of fistula | 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 |
| Evaluation of Fecal Incontinence Score |
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Inclusion Criteria:
Exclusion Criteria:
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• the patients with complete closure at week 8 after last injection in ANTG-ASC-210 trials
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| Name | Affiliation | Role |
|---|---|---|
| KJ Park | Seoul National University Hospital | Principal Investigator |
| DS Kim | Daehang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DaeHang Hospital | Seoul | South Korea | ||||
| Seoul National University Hospital |
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|
| Autologous adipose derived stem cells(high dose group) | Biological | 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. |
|
|
Evaluation of Fecal Incontinence Score (Wexner Score, Cleveland Clinic Continence Scoring System) |
| Month 4 |
| Grade of Investigator's satisfaction | Grade of Investigator's satisfaction (Month 2, 4)
| Month 2, 4 |
| Number of patients with adverse events as a measure of systemic tolerance and physical examinations |
| Month 2, 4 |
| Seoul |
| South Korea |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D005402 | Fistula |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
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