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Adipose-derived stem cells have properties of differentiation to various types of cells, immunomodulatory effects. adipose-derived stem cells (ASCs) show also low immunogenicity.
Anterogen has developed ANTG-ASC(Autologous ASC) which has shown good efficacy and safety in Phase I and II study on the patients with Crohn's fistula.
However, Crohn's patients are sometimes not fat enough to extract fat tissue for culturing ASCs. Therefore the investigators have planned to study allogenic ASCs for safety and efficacy in patients with Crohn's fistula.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | For ALLO-ASC 1xE7 cells/ml,3 patients are to be enrolled. If there is no safety issue, 3 more patients will be enrolled to be treated with ALLO-ASC 3xE7 cells/ml. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogenic human adipose-derived stem cells | Biological | ALLO-ASC 1xE7 cells/mL is injected once along the fistula. If there is no safety issue for 4 weeks, 3 more people could be enrolled who are subject to ALLO-ASC 3xE7 cells/mL. |
| Measure | Description | Time Frame |
|---|---|---|
| General safety (Laboratory screening, adverse effects, immunological response, local tolerance) | Week8 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with sustained efficacy | Proportion of patients with more than 50% healed fistula at Month 8 Following up whether there is a recurrence at Month 8 | Month 8 |
| Proportion of patients with adverse effects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| TI Kim, MD, PhD | Yeonsei Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keonghee Medical Center | Seoul | South Korea | ||||
| Seoul National University Hospital |
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|
Evaluate the safety at 8 months whether any kind of AE occurs.
| at month 8 |
| Seoul |
| South Korea |
| Yeonsei Medical Center | Seoul | South Korea |