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The overall goal of this study is to evaluate the safety and exploratory efficacy of the injectable filler agent composed of umbilical cord mesenchymal stem cells and hyaluronic acid for the improvement of wrinkles, acne, pitting scar and so on.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UCMSCs-HA | Experimental | Multipoint of Transdermal injection into the wrinkles. Injectable filler agent composed of umbilical cord mesenchymal stem cells (UCMSCs) and hyaluronic acid (HA). |
|
| Control | Active Comparator | Procedure: Transdermal injection of hyaluronic acid only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| umbilical cord mesenchymal stem cells and hyaluronic acid | Biological |
| ||
| hyaluronic acid |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with non-serious and serious adverse events | Change from baseline up to week 12 after injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Wrinkle Severity Rating Scale (WSRS) Evaluation | An improvement was judged by the outcome of the preoperative grade minus the postoperative grade in accordance with the Wrinkle Severity Rating Scale (WSRS).The severity was measured using the Wrinkle Severity Rating Scale (WSRS), where 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Extreme, which is an ordinal scale. | Change from baseline at week 2, 6 and 12. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuetao Pei, M.D., Ph.D | Contact | 8610-68164807 | AMMS0906@163.com | |
| Fang Fang, Ph.D | Contact | 8620-89199011 | fangfang@scrm.org.cn |
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| Drug |
|
| Global Aesthetic Improvement Scale (GAIS) Evaluation | An improvement was judged by the outcome of the preoperative grade minus the postoperative grade in accordance with the Global Aesthetic Improvement Scale (GAIS). | Change from baseline at week 2, 6 and 12. |
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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