The Effect of Autologous Stromal Vascular Fractions on Skin Regeneration

Study Overview
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Brief Summary
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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
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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

Official Title
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Study of Autologous Stromal Vascular Fraction From Adipose Tissue in Promoting Skin Regeneration

Conditions
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Skin, Aging

Intervention / Treatment
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* Biological: stromal vascular fraction
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stromal vascular fraction<br>Transplantation of resuspended SVF | Biological: stromal vascular fraction<br>* 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.<br>* Other names: heterogeneous cell populations isolated from adipose tissue;|
| Placebo Comparator: saline<br>1 ml saline without cells will be used as placebo. | Drug: Saline<br>* 1 ml saline was injected for 3 area including the forehead、palpebra inferior and crow's-feet.<br>* Other names: normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the texture changes of the skin | Using Cutometer® dual MPA 580 in 12 months post the treatment. | Baseline and 12 months post the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the colour changes of the skin | Using Canfield Scientific VISIA in 12 months post the treatment. | Baseline and 12 months post the treatment | 
| Occurence of major adverse events | Including skin necrosis, infection, erythra and all other adverse events | Up to approximately 12 months after study start | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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skin regeneration, anti-aging, stromal vascular fraction, skin texture