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This is a phase II single-blinded study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Diabetic Foot Ulcer, compared to standard therapy.
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 | Experimental | Allogeneic mesenchymal stem cells |
|
| Standard therapy | Active Comparator | Standard therapy for patients with diabetic foot ulcer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALLO-ASC-DFU | Biological | Application of ALLO-ASC-DFU sheet to diabetic foot ulcer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of re-epithelialization | During 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of re-epithelialization | During 12 weeks | |
| Time to re-epithelialization | During 12 weeks | |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |
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Inclusion Criteria:
Subject is between 18 years and 80 years of age.
Subject is diagnosed with Type I or Type II diabetes, and had defined as diabetic foot ulcers presence of wound for more than 4 weeks at the screening visit.
Ulcer located the foot, and ulcer size is between 1 cm^2 and 25 cm^2.
Ulcer extends into the dermis, subcutaneous tissue, tendon or joint capsule (Wagner grade 1 or 2).
Ulcer is free of necrotic debris.
Subjects had adequate circulation to ulcer as documented by one of the methods below:
Subject is able to give written informed consent prior to study start and to comply with the study requirements.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seung-Kyu Han, MD. PhD. | Korea University Guro Hospital | Principal Investigator |
| Ki-Won Young, MD. PhD. | Eulji General Hospital | Principal Investigator |
| Hyun-suk Suh, MD. PhD. | Asan Medical Center | Principal Investigator |
| Jin Woo Lee, MD. PhD. | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Guro Hospital | Guro-gu | Seoul | 08308 | South Korea | ||
| Eulji General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30679183 | Derived | Moon KC, Suh HS, Kim KB, Han SK, Young KW, Lee JW, Kim MH. Potential of Allogeneic Adipose-Derived Stem Cell-Hydrogel Complex for Treating Diabetic Foot Ulcers. Diabetes. 2019 Apr;68(4):837-846. doi: 10.2337/db18-0699. Epub 2019 Jan 24. |
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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 |
|
| Follow up to 12 weeks |
| Nowon-Gu |
| Seoul |
| 01830 |
| South Korea |
| Severance Hospital | Seodaemun-Gu | Seoul | 03722 | South Korea |
| Asan medical center | Songpa-Gu | Seoul | 05505 | 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 |