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Difficulty recruiting subjects.
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Mesenchymal stem cells derived from adipose tissue are pluripotent to differentiate into myocytes, adipocytes or others. They have an immunosuppressive activity. Complex perianal fistula is difficult to cure and easy to relapse. Autologous adipose stem cells have shown efficacy and safety on Crohn's fistula in phase 1 study. Based on these results, the investigators would apply autologous adipose stem cells on complex perianal fistula to evaluate their efficacy and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Low dose group |
|
| Group 2 | Experimental | high dose group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous cultured 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 complete closure of fistula (week 8) | Proportion of patients with completely closed fistula (week 8) | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Grade of investigator's satisfaction | Grade of investigator's satisfaction (8 weeks after final dose)
| 8 weeks |
| Number of patients with closed fistula |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| KJ Park, MD, PhD | Seoul National University Hospital | Principal Investigator |
| DS Kim | Daehang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soon cheun Hyang university bucheon hospital | Bucheon-si | 420-767 | South Korea | |||
| Ewha womwn university mokdong hospital |
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|
|
| Autologous cultured 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. |
|
|
|
| 8 weeks |
| Photo of target fistula | Taking picture of target fistula at Day 0 and Week 4, 6, 8 | 8 weeks |
| Number of patients with adverse events | Number of patients with any kinds of adverse events (Day 0, every visits) | 8 weeks |
| Seoul |
| 158-710 |
| 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 |
| 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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