Investigate the effect of dermal/subcutaneous injection of ASC enriched fat transplant in a protective natural scaffold, designed to sustain the ASC viability after dermal/subcutaneous injection.
The study investigates the effect of different concentrations of autologous ex-vivo expanded adipose-derived stromal cells (ASCs), fat and a natural scaffold for skin rejuvenation and augmentation. The aim is to better the volume of fat grafts for cosmetic and reconstructive purposes. Fat is a near ideal filler, as it is biocompatible. However the retention rate of fat grafts often result in poor outcomes and it is unpredictable. The investigators have set up an experimental study in which participants with excess abdominal skin is recruited. They will have injections with 11 different solutions of fat, ACSs, scaffold and dermal CO2 laser in the abdominal skin. After 3 months biopsies will be taken and after 6 months all of the treated area will be removed by an cosmetic abdominoplasty.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
5
eight different solutions of fat, ASCs, scaffold and CO2 laser in dermis three different solutions of fat, ASCs and scaffold in the subcutaneous layer
Aleris Hamlet
Copenhagen, Søborg, Denmark
StemMedical
Copenhagen, Søborg, Denmark
Volume assessment
CT scan
Time frame: Baseline, three months, Six months
Cell count, immunohistochemistry, skin quality
Cell count, immunohistochemistry, skin quality
Time frame: Three months, six months
Immunohistochemistry
Immunohistochemistry
Time frame: Three months, six months
Skin thickness
Skin thickness
Time frame: Three months, six months
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