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This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 1 clinical trial (ALLO-ASC-DFU-101) for 23 months.
This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 1 clinical trial (ALLO-ASC-DFU-101) for 23 months.
ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a Diabetic Foot Ulcer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALLO-ASC-DFU treatment | Subjects with ALLO-ASC-DFU treatment in phase 1 clinical trial of ALLO-ASC-DFU-101 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALLO-ASC-DFU | Biological | ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide an new option in treating a diabetic foot ulcer. This study is a follow-up study without intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Evaluation of AE | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Wound size and depth measurement | Evaluation of the improvement of wound measured by size and depth, and examines the change for 23 months period | 6, 12, 24 months |
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Inclusion Criteria:
Exclusion Criteria:
1. Subjects who are considered not suitable for the study by the principal investigator (For example, Subjects requiring surgical procedure on target site).
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Subject is enrolled who are treated with ALLO-ASC-DFU sheet in phase 1 clinical trial of ALLO-ASC-DFU-101.
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| Name | Affiliation | Role |
|---|---|---|
| Hyun-suk Suh, MD, PhD | Asan Medical Center | Principal Investigator |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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|
|
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |