Study of Autologous Stromal Vascular Fraction From Adipose Tissue in Promoting Skin Regeneration
Overview
- Phase
- Phase 1
- Intervention
- stromal vascular fraction
- Conditions
- Skin
- Sponsor
- Shanghai Jiao Tong University School of Medicine
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Measure the texture changes of the skin
- Last Updated
- 8 years ago
Overview
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
Investigators
Qing-FengLi Li,MD
MD, PhD, Professor, Head of Departement of Plastic and Reconstructive Surgery, Shanghai 9th People's Hospital
Shanghai Jiao Tong University School of Medicine
Eligibility Criteria
Inclusion Criteria
- •Age of 18 to
- •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.
Arms & Interventions
stromal vascular fraction
Transplantation of resuspended SVF
Intervention: stromal vascular fraction
saline
1 ml saline without cells will be used as placebo.
Intervention: Saline
Outcomes
Primary Outcomes
Measure the texture changes of the skin
Time Frame: Baseline and 12 months post the treatment
Using Cutometer® dual MPA 580 in 12 months post the treatment.
Secondary Outcomes
- Measure the colour changes of the skin(Baseline and 12 months post the treatment)
- Occurence of major adverse events(Up to approximately 12 months after study start)