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The purpose of the present study is to evaluate the safety and exploratory efficacy of the medical collagen membrane with umbilical cord derived mesenchymal stem cells in the treatment of patients with skin defects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical Collagen Membrane with MSC | Experimental | Applications of medical collagen membrane with umbilical cord derived mesenchymal stem cells (MSC). |
|
| Medical Collagen Membrane | Active Comparator | Application of medical collagen membrane only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical Collagen Membrane with MSC | Device |
| ||
| Medical Collagen Membrane |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events that are related to study treatment and associated with the grafting site | Up to Month 36 after the last grafting day | |
| Percentage of wound closure as determined | Up to Month 3 after the last grafting day |
| Measure | Description | Time Frame |
|---|---|---|
| Scar outcome assessment | Up to Month 36 after the last grafting day | |
| Incidence of contracture release or revision surgeries | Up to Month 36 after the last grafting day | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuetao Pei, M.D., Ph.D | Contact | 0086-10-68164807 | peixuetao@scrm.org.cn | |
| Bowen Zhang, Ph.D | Contact | 0086-10-66931947 | zhangbowen@scrm.org.cn |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17653662 | Background | He L, Nan X, Wang Y, Guan L, Bai C, Shi S, Yuan H, Chen L, Liu D, Pei X. Full-thickness tissue engineered skin constructed with autogenic bone marrow mesenchymal stem cells. Sci China C Life Sci. 2007 Aug;50(4):429-37. doi: 10.1007/s11427-007-0069-2. |
| Label | URL |
|---|---|
| Related Info | View source |
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| Device |
|
| Incidence of increased temperature sensitivity |
| Up to Month 36 after the last grafting day |
| Incidence of paresthesias, pain, dulling of sensation assessed | Up to Month 36 after the last grafting day |
| Incidence and severity of infections at grafting sites | Up to Month 6 after the last grafting day |
| Incidence of all adverse events | Up to Month 36 after the last grafting day |
| Percentage area of re-grafting as determined | Up to Month 6 after the last grafting day |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D017719 | Diabetic Foot |
| D002056 | Burns |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| 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 |
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