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This is a follow-up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial (ALLO-ASC-DFU-302) for 24 months
This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial (ALLO-ASC-DFU-302) for 24 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 3 clinical trial of ALLO-ASC-DFU-302 |
| |
| Vehicle sheet | Subjects with Vehicle sheet treatment in phase 3 clinical trial of ALLO-ASC-DFU-302 |
|
| 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 |
|---|---|---|
| Evaluation of systemic tolerance through incidence of abnormal laboratory test results | Up to 9 months | |
| Evaluation of incidence of clinically significant change in physical examination and vital signs | Up to 18 months | |
| Evaluation of localized tolerance through incidence of clinically significant change about treatment area | Up to 24 months | |
| Evaluation of incidence of adverse events | 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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ubjects who are treated with ALLO-ASC-DFU sheet or Vehicle sheet in phase 3 clinical trial of ALLO-ASC-DFU-302.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ChangSik Park, MD. Ph D | Contact | +82 2 3010 3600 | iloveps.jcp@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| ChangSik Park, MD. Ph D | Asan Medical Center | Principal Investigator |
| JiUng Bak, MD. Ph D | Borame Medical Center | Principal Investigator |
| DaeWon Jun, MD. Ph D |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soonchunhyang University Hospital | Recruiting | Bucheon-si | Gyeonggi-do | 14584 | South Korea |
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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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| Vehicle sheet | Procedure | Application of Vehicle sheet to Diabetic Foot Ulcer. This study is a follow-up study without intervention. |
|
| Bucheon St. Mary's Hospital |
| Principal Investigator |
| YoungKoo Lee, MD. Ph D | Soonchunhyang University Hospital | Principal Investigator |
| Bucheon ST. Mary's Hospital | Recruiting | Bucheon-si | Gyeonggi-do | 14647 | South Korea |
|
| Asan Medical Center | Recruiting | Seoul | 05505 | South Korea |
|
| Borame Medical Center | Recruiting | Seoul | 07061 | 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 |