Aging, Skin
Conditions
Keywords
stromal vascular fraction, skin regeneration, skin texture, anti-aging
Brief summary
The purpose of this study is to observe whether the transplantation of autologous stromal vascular fraction (SVF) in adipose tissue is safe and its effect on improving skin regeneration.
Detailed description
This is a randomized controlled single blind clinal trial that designed to observe whether the transplantation of autologous stromal vascular fraction (SVF) in adipose tissue is safe and its effect on improving skin regeneration. The clinical trial will concentrate on the therapeutic effect of SVF after facial injection. After 1, 4, 8, 12, 24 and 48 weeks of treatment, a comprehensive examination of the facial skin was performed to assess the effect of the SVF. Skin texture, thickness and colour will be observed to evaluate the effect of SVF on skin regeneration
Interventions
BIOLOGICALstromal vascular fraction
The adipose tissue(no less than 40ml) in abdomen will be harvested and digested at 37 °C for (45-60) min with (0.125-1.5)mg/ml collagenase . After filtration and centrifugation at the speed of (700-1500)g, mature adipocytes are separated from the cell pellet. The pellet then is treated with saline twice to remove cell fragment and rudimental collagenase . The harvested pellet is stromal vascular fraction (SVF) The SVF was resuspended in 1 ml saline and transplanted for 3 area including the forehead、palpebra inferior and crow's-feet.
DRUGSaline
1 ml saline was injected for 3 area including the forehead、palpebra inferior and crow's-feet.
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Age of 18 to 65. * No other facial plastic surgery or cosmetic surgery was performed during the study period (frontal, temporal, and lower eyelid). * Intends to undergo facial anti-aging treatment with SVF
Exclusion criteria
* Not fit for stem cells graft treatment. * Evidence of infection, ischemia, ulcer or other pathological changes within the targeting area which defined as not suitable for SVF treatment; or history of delayed healing, radiational therapy. * Significant renal, cardiovascular, hepatic and psychiatric diseases. * Significant medical diseases or infection (including but not limited to the carrier of hepatitis B virus or HIV). * Used external medication on the targeting area within 4 weeks. * Skin invasive treatment including laser on the targeting area within 6 months. * Hyaluronic acid injection on the targeting area within 12 months. * Botulinum toxin injection on the targeting area within 6 months. * History of any hematological disease, including leukopenia , thrombocytopenia, or thrombocytosis. * Evidence of malignant diseases or unwillingness to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure the texture changes of the skin | Baseline and 12 months post the treatment | Using Cutometer® dual MPA 580 in 12 months post the treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure the colour changes of the skin | Baseline and 12 months post the treatment | Using Canfield Scientific VISIA in 12 months post the treatment. |
| Occurence of major adverse events | Up to approximately 12 months after study start | Including skin necrosis, infection, erythra and all other adverse events |
Countries
China
Contacts
Primary ContactLi Qingfeng, MD; PhD
Backup ContactHe Jizhou, MD
Outcome results
None listed