Clinical trial NCT02546882: The Improving Effect of Autologous Stromal Vascular Fraction (SVF) in Adipose Tissue on Skin Grafting
Official title: Phase 1/2 Study of Autologous Stromal Vascular Fraction in Adipose Tissue Transplantation in Improving Skin Grafting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Skin; Deformity, Due to Scar
Keywords: stromal vascular fraction
skin graft
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: West China Hospital
name: Guangzhou General Hospital of Guangzhou Military Command
name: Second Affiliated Hospital of Suzhou University
name: The First People's Hospital of Zhaoqing City
name: Wuhan Third Hospital
First posted: 2015-09-11
Enrollment: 75
Sex: ALL
Minimum age (years): 3
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 the texture and contracture of skin grafting.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Measure the texture and colour change of the skin using Cutometer® dual MPA 580 and questionnaires in 6 months post the treatment.
timeFrame: 6 months post the treatment.
Secondary outcomes:
measure: Occurence of major adverse events
timeFrame: Up to approximately 18 months after study start
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
name: Qingfeng Li, MD, PhD
role: STUDY_DIRECTOR
References: