Skin; Deformity, Due to Scar Clinical Trial
Official title:
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment