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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 2 clinical trial (ALLO-ASC-DFU-201) 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 2 clinical trial (ALLO-ASC-DFU-201) 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 | Subjects with ALLO-ASC-DFU treatment in phase 2 clinical trial of ALLO-ASC-DFU-201 |
| |
| Standard therapy | Subjects with Standard therapy in phase 2 clinical trial of ALLO-ASC-DFU-201 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALLO-ASC-DFU | Biological | Application of ALLO-ASC-DFU sheet to 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 |
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Inclusion Criteria:
Exclusion Criteria:
1. Subjects who are considered not suitable for the study by the principal investigator.
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Subject is enrolled who are treated with ALLO-ASC-DFU sheet in phase 2 clinical trial of ALLO-ASC-DFU-201.
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| Name | Affiliation | Role |
|---|---|---|
| Seung-Kyu Han, MD. Ph D. | Korea University Guro Hospital | Principal Investigator |
| Ki-Won Young, MD. Ph D. | Eulji General Hospital | Principal Investigator |
| Hyun-suk Suh, MD. Ph D. | Asan Medical Center | Principal Investigator |
| Jin Woo Lee, MD. Ph D. | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eulji General Hospital | Seoul | 01830 | South Korea | |||
| Severance Hospital |
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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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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard therapy | Other | Standard therapy conducted for patients with diabetic foot ulcer. This study is a follow-up study without intervention. |
|
| Seoul |
| 03722 |
| South Korea |
| Asan medical center | Seoul | 05505 | South Korea |
| Korea University Guro Hospital | Seoul | 08308 | South Korea |
| 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 |