The Effect of Autologous Stromal Vascular Fractions on Skin Regeneration

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

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.

Study Overview

• Status: Unknown
• Conditions: Aging; Skin
• Intervention / Treatment: Biological: stromal vascular fraction; Drug: Saline

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Li Qingfeng, MD; PhD; Phone Number: 0086 21 63089567; Email: dr.liqingfeng@yahoo.com
• Study Contact Backup: Name: He Jizhou, MD; Phone Number: 0086 21 15800806993; Email: michael_he@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200011
      • Recruiting
      • Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine
      • Contact: Li Qing Feng, MD; PhD; Phone Number: 0086 21 63089567; Email: dr.liqingfeng@yahoo.com
      • Contact: He Ji Zhou, MD; Phone Number: 0086 21 15800806993; Email: michael_he@126.com
      • Principal Investigator: Li Qingfeng, MD, PhD
      • Sub-Investigator: Xie Yun, MD
      • Sub-Investigator: He Jizhou, MD
      • Sub-Investigator: Cheng chen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Investigators: Study Chair: Li Qingfeng, MD; PhD, Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2017
• Primary Completion (Anticipated): August 25, 2017
• Study Completion (Anticipated): March 13, 2018

Study Registration Dates

• First Submitted: May 22, 2017
• First Submitted That Met QC Criteria: June 14, 2017
• First Posted (Actual): June 16, 2017

Study Record Updates

• Last Update Posted (Actual): June 16, 2017
• Last Update Submitted That Met QC Criteria: June 14, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: anti-aging; stromal vascular fraction; skin regeneration; skin texture
• Other Study ID Numbers: 2016-261-T196

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No