The Effect of Autologous Stromal Vascular Fractions on Skin Regeneration

Phase 1

• Conditions: Skin; Aging
• Interventions: Drug: Saline; Biological: stromal vascular fraction

• Registration Number: NCT03189628
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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

Study Timeline

• Study Start: 2017-03-13
• Study First Submitted: 2017-05-22
• Status Verified: 2017-06
• Study First Submitted QC: 2017-06-14
• Last Update Submitted: 2017-06-14
• Study First Posted: 2017-06-16
• Last Update Posted: 2017-06-16
• Primary Completion: 2017-08-25
• Study Completion: 2018-03-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
saline	Saline	1 ml saline without cells will be used as placebo.
stromal vascular fraction	stromal vascular fraction	Transplantation of resuspended SVF

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China