Skin Inflammation, Stem Cell Transplant Complications
Conditions
Brief summary
The aim of this study is the safety and efficacy of autologous very small embryonic-like stem cells(VSELs) to facial skin antiaging.
Detailed description
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.
Interventions
BIOLOGICALVery small embryonic-like stem cell
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
Sponsors
Guangzhou Four-Leaf Clover HealthTech Co., Ltd.
Fuda Cancer Hospital, Guangzhou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
The volunteers will be randomly arranged to enter the experimental group or the control group.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
• Healthy volunteers with anti-aging willingness
Exclusion criteria
* Metabolic and systemic diseases such as diabetes and atherosclerosis * Facial skin diseases such as herpes, eczema, skin rash, systemic lupus erythematosus, dermatomyositis, connective tissue disease * Endocrine disorders and cancer patients Blood disease patients, thrombocytopenia or dysfunction, hypofibrinemia or anticoagulant therapy, long-term use of aspirin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-emergent adverse events | 1 week | Swelling in the skin at the injection site |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short-term changes in skin histopathology | 3-6 months after injection | 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 |
| Long-term changes in skin histopathology | 12 months after final injection | 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 |
Countries
China
Outcome results
None listed