The Effect of Autologous Stromal Vascular Fractions on Skin Regeneration

Shanghai Jiao Tong University School of Medicine

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Aging; Skin

Treatments: Drug: Saline; Biological: stromal vascular fraction

Study type: Interventional

Funder types: Other

Identifiers

NCT03189628

2016-261-T196

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

stromal vascular fraction

Experimental group

Description:

Transplantation of resuspended SVF

Treatment:

Biological: stromal vascular fraction

saline

Placebo Comparator group

Description:

1 ml saline without cells will be used as placebo.

Treatment:

Drug: Saline