Evaluation of the Effect of Autologous Fat and SVF Transplantation in Promoting Mechanical-stretch Induced in Vivo Skin Regeneration

The purpose of this study is to evaluating whether autologous grafted fat transplantation or SVF transplantation is safe and/or effective to accelerating skin regeneration and soft tissue expansion.

Study Overview

• Status: Unknown
• Conditions: Scar
• Intervention / Treatment: Procedure: FAT-GRAFT; Procedure: SVF-TRANSPLANTATION; Procedure: PLACEBO

Detailed Description

Reconstruction of large scale skin defect is a challenge to clinical surgeons. Soft tissue expansion has won wide attention in recent years as it promotes skin regeneration with perfectly matched tissue. However, some patients with poor skin regenerative ability would suffer from skin flap over-thinned and even necrosis under the continuous stretching by silicone expander. This study is to evaluate the effects of autologous fat graft/SVF transplantation on accelerating skin regeneration and promoting tissue expansion process.

Patients aged between 18 to 60 years old who appear with deteriorated expanded skin will be enrolled and randomized into three groups, named as the experimental group and the control group. Patients from the FAT-GRAFT group will have a liposuction and subdermal fat graft transplantation. Patients from the SVF-TRANSPLANTATION group will have a liposuction and SVF will be separated and transplanted intradermally to expanded skin. Patients from the control group will have saline injection.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Qing-Feng Li, M.D., Ph.D.; Phone Number: 00862123271699

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Shanghai Ninth People's Hospital
    • Contact: Qing-Feng Li, M.D., Ph.D.
  • Shanghai
    • Shanghai, Shanghai, China, 200011
      • Recruiting
      • Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine
      • Contact: Qingfeng Li, MD, PhD; Phone Number: 0086 21 63089567; Email: liqfliqf@yahoo.com.cn
      • Contact: Shuangbai Zhou, MD; Phone Number: 0086 13482514585; Email: shuangbaizhou@gmail.com
      • Principal Investigator: Qingfeng Li, MD, PhD
      • Sub-Investigator: Shuangbai Zhou, MD
      • Sub-Investigator: Yun Xie, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Inclusion Criteria:
• Age of 18 to 60 years;
• Expanding skin donor site at the face, neck, anterior chest wall, abdominal wall or back;
• Implanted silicone expander of 80 to 600 ml in size;
• History of deterioration in the expanded skin texture that did not improve after the inflation procedure was suspended for more than 2 weeks;
• Persistent high level of expander internal pressure;
• Need for further skin expansion;

Exclusion Criteria:

• Not fit for soft tissue expansion treatment;
• Evidence of infection, ischemia, ulcer or other pathological changes within the targeting area which defined as not suitable for expansion; 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)
• BMI >30;
• History of any hematological disease, including leukopenia , thrombocytopenia, or thrombocytosis;
• History of allogenic bone marrow transplantation;
• Long history of smoking;
• 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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FAT-GRAFT; Fat graft transplantation	Procedure: FAT-GRAFT; Liposuction will be performed and autologous fat graft will be harvest after washing with saline. Patients will receive autologous fat graft transplantation subdermally to expanded skin at the density of 0.1 ml/cm2.
Experimental: SVF-TRANSPLANTATION; Transplantation of resuspended SVF	Procedure: SVF-TRANSPLANTATION; Liposuction will be performed. SVF will be separated from autologous fat graft by collagenase digestion. Patients will receive resuspended SVF transplantation subdermally to expanded skin at the density of 1*10e6 cells/cm2.
Placebo Comparator: CONTROL; Same volume saline injection	Procedure: PLACEBO; Saline will be injected into expanded skin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurence of Major Adverse Events	Including expanded flap ischaemia, necrosis, fluidify, infection, and all other adverse events	Up to approximately 24 months after study start
To Measure the Change in Inflation Volume of the Silicone Expander from Baseline at 8 weeks	Record the inflation volume of each expander with the maintained inner pressure.	baseline and 8 weeks post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To Measure the Size of Expanded Flap with 3D laser scanner and calculate the surface of expanded skin	Record the outface of expanded skin flap with 3D laser scanner and calculate the surface of expanded skin	baseline and 8 weeks post treatment
To Measure the Texture of Expanded Flap with VISIA scanner	Evaluate skin texture with VISIA scanner and compare the characteristics	4 weeks and 8 weeks post treatment
To Measure Expanded Skin Thickness by Ultrasound Scanning	Measure the dermal and epidermal thickness of expanded skin by ultrasound scanning	baseline, 4 weeks and 8 weeks post treatment

Collaborators and Investigators

• Sponsor: Qing-FengLi Li,MD

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: December 26, 2014
• First Submitted That Met QC Criteria: January 8, 2015
• First Posted (Estimate): January 13, 2015

Study Record Updates

• Last Update Posted (Estimate): April 20, 2016
• Last Update Submitted That Met QC Criteria: April 18, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: skin regeneration; mechanical stretch
• Other Study ID Numbers: [2014]47