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Policy changes have contributed to the failure to carry out smoothly
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| Name | Class |
|---|---|
| Guangzhou Four-Leaf Clover HealthTech Co., Ltd. | INDUSTRY |
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The aim of this study is the safety and efficacy of autologous very small embryonic-like stem cells(VSELs) to facial skin antiaging.
VSELs come from the patient's peripheral blood, and will be injected in left preauricular area, followed by skin pathology to compare the improvement of skin aging. Two 0.5 × 1 cm fragments of skin and subcutaneous tissue was removed from bilateral preauricular areas for morphologic analysis by optical and electron microscopy. Histologic analysis of skin biopsy specimens was performed by hematoxylin and eosin, picrosirius red (for visualization of collagen), and orcein (for visualization of elastic fibers) staining.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VSEL Max | Experimental | We carried out the subdermal application of VSELs with a 1-mL syringe (90,000 cells in 0.4 mL plate-rich plasma) coupled to a 30-gauge needle, in the left preauricular area (1-cm2 area), 2 cm distal from the tragus |
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| VSEL Medium | Experimental | We carried out the subdermal application of VSELs with a 1-mL syringe (60,000 cells in 0.4 mL plate-rich plasma) coupled to a 30-gauge needle, in the left preauricular area (1-cm2 area), 2 cm distal from the tragus |
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| VSEL Mini | Experimental | We carried out the subdermal application of VSELs with a 1-mL syringe (30,000 cells in 0.4 mL plate-rich plasma) coupled to a 30-gauge needle, in the left preauricular area (1-cm2 area), 2 cm distal from the tragus |
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| Control | No Intervention | Subcutaneous injection of 0.4 mL platelet-rich plasma in the same part of the experimental group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Very small embryonic-like stem cell | Biological | We carried out the subdermal application of VSELs with a 1-mL syringe (volume, 0.4 mL) coupled to a 30-gauge needle, in the left preauricular area (1-cm2 area), 2 cm distal from the tragus |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events | Swelling in the skin at the injection site | 1 week |
| Incidence of treatment-emergent adverse events | Color change, pain in the skin at the injection site | 1 week |
| Incidence of treatment-emergent adverse events | Pain in the skin at the injection site | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Short-term changes in skin histopathology | Two 0.5 × 1 cm fragments of skin and subcutaneous tissue was removed from the bilateral preauricular areas for morphologic analysis by optical and electron microscopy | 3-6 months after injection |
| Long-term changes in skin histopathology |
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Inclusion Criteria:
• Healthy volunteers with anti-aging willingness
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biological treatment center in Fuda cancer hospital | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D003872 | Dermatitis |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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In the experimental group, VSELs will be injected in left preauricular area of every volunteer, followed by skin pathology to compare the improvement of skin aging with the skin of right preauricular area. In the control group, platelet-rich plasma will be injected to the left preauricular area of every volunteer.
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The volunteers will be randomly arranged to enter the experimental group or the control group.
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Two 0.5 × 1 cm fragments of skin and subcutaneous tissue was removed from the bilateral preauricular areas for morphologic analysis by optical and electron microscopy |
| 12 months after final injection |