The Improving Effect of Autologous Stromal Vascular Fraction (SVF) in Adipose Tissue on Skin Grafting

Phase 1/2 Study of Autologous Stromal Vascular Fraction in Adipose Tissue Transplantation in Improving Skin Grafting

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 the texture and contracture of skin grafting.

Study Overview

• Status: Unknown
• Conditions: Skin; Deformity, Due to Scar
• Intervention / Treatment: Biological: stromal vascular fraction; Drug: saline

Detailed Description

Reconstruction of large scale skin defect is still a challenge for clinical surgeons. The application of skin grafting works as an important choice, however, the strong contracture and poor appearance limit its wide application in scar repair. The stromal vascular fraction (SVF) of adipose tissue is a group of heterogeneous cells including multipotential mesenchymal cells, preadipocytes, endothelial cells, fibroblasts, macrophages and smooth muscle cells. Previous researches have reported that SVF could secrete various angiogenic growth factors in vitro and enhance neovascularisation of ischaemic tissue in vivo. The Adipose-derived Stem cells in the SVF are multipotential stem cells which have the ability to regenerate, while differentiating to become adipose tissue and help to improve the texture of the grafted skin. Besides, SVF is easy to be harvested in large numbers with less donor injury and can be used directly after isolation without in vitro culture, which makes it a good alternative for regenerative medicine.This study is to observe the effect of autologous SVF on improving the texture and contracture of skin grafting.

Patients requiring skin graft of 2 symmetry parts of the body between the age of 3 and 70 years will be enrolled and randomized into two groups, named as the experimental group with SVF transplantation and the control group with no cell transplantation. Patients from the experimental group will have a fat aspiration on the surgery day. The adipose tissue in abdomen or thigh will be digested at 37 °C for 60 min with 0.2% collagenase IV. After filtration and centrifugation, mature adipocytes are separated from the cell pellet. The pellet then is treated with erythrocyte lysis buffer twice to remove red cell fragment. The harvested pellet is SVF. The SVF will be resuspended in saline and transplanted between the grafted skin and the wound with 1 million cells for 1 cm2 area. Skin thickness, texture, contracture and colour will be observed to measure the effect of SVF on skin grafting post treatment.

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Qingfeng Li, MD, PhD; Phone Number: 0086 21 63089567; Email: dr.liqingfeng@yahoo.com
• Study Contact Backup: Name: Hua Li, MD, PhD; Phone Number: 0086 18621871963; Email: laputanlee@hotmail.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: Qingfeng Li, MD, PhD; Phone Number: 0086 21 63089567; Email: dr.liqingfeng@yahoo.com
      • Contact: Hua Li, MD, PhD; Phone Number: 0086 18621871963; Email: lanputanlee@hotmail.com
      • Principal Investigator: Qingfeng Li, MD,PhD
      • Sub-Investigator: Hua Li, MD, PhD
      • Sub-Investigator: Xiyuan Mao, MM
      • Sub-Investigator: Chen Cheng, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• With symmetrical scar or soft tissue deficiencies requiring skin graft therapy.
• Age of 3 to 70.
• Have no underlying disease except skin scar deformity.
• Have enough healthy donor site skin for both sides of receiving area.

Exclusion Criteria:

• Not fit for skin graft treatment;
• Evidence of infection, ischemia, ulcer or other pathological changes within the targeting area which defined as not suitable for skin grafting; 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;
• Alcohol abuse
• 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
Experimental: stromal vascular fraction; The adipose tissue in abdomen or thigh will be harvested and digested at 37 °C for 60 min with 0.2% collagenase I/Ⅲ. After filtration and centrifugation, mature adipocytes are separated from the cell pellet. The pellet then is treated with erythrocyte lysis buffer twice to remove red cell fragment. The harvested pellet is stromal vascular fraction (SVF).	Biological: stromal vascular fraction; 1million stromal vascular fraction was resuspended in 1 ml saline and transplanted for 1 cm2 area.; Other Names: heterogeneous cell populations isolated from adipose tissue
Placebo Comparator: saline; 1 ml saline without cells will be used as placebo.	Drug: saline; 1 ml saline was injected for 1 cm2 area.; Other Names: normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure the texture and colour change of the skin using Cutometer® dual MPA 580 and questionnaires in 6 months post the treatment.	Questionnaires scores satisfaction range from 0(not satisfied with the result) to 10(good result)	6 months post the treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurence of major adverse events	Including skin graft ischaemia, necrosis, infection, and all other adverse events	Up to approximately 18 months after study start

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Collaborators: West China Hospital; Guangzhou General Hospital of Guangzhou Military Command; Second Affiliated Hospital of Suzhou University; The First People's Hospital of Zhaoqing City; Wuhan Third Hospital
• Investigators: Study Director: Qingfeng Li, MD, PhD, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: January 23, 2014
• First Submitted That Met QC Criteria: September 9, 2015
• First Posted (Estimate): September 11, 2015

Study Record Updates

• Last Update Posted (Estimate): September 11, 2015
• Last Update Submitted That Met QC Criteria: September 9, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: stromal vascular fraction; skin graft
• Additional Relevant MeSH Terms: Skin Diseases; Congenital Abnormalities; Skin Abnormalities
• Other Study ID Numbers: 2012BAI11B03 (Other Grant/Funding Number: Scientific and Technical Supporting Programs)