Dermal and Subcutaneous Augmentation and Skin Assessment After Fat-, Stem Cell and Scaffold Injections

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Examining the Best Solution for Dermal and Subcutaneous Augmentation and Regeneration Using Ex-vivo Expanded Autologous Adipose-derived Stromal Cells, Autologous Fat Tissue and Natural Tissue Scaffolds

Conditions
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Augmentation, Reconstruction

Intervention / Treatment
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* Biological: Scaffold and adipose-derived stromal cell enriched fat grafts


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI between 18-30 kg/m2 400 mL of fat (lipoaspirate) available for liposuction in the thighs or back Desire for abdominoplasty Speaks and reads Danish Signed informed consent Exclusion Criteria: Smoking Previous major abdominal surgery Previous cancer or predisposition to cancer Pregnancy or planned pregnancy Known chronic disease associated with metabolic malfunction or poor healing Pacemaker Allergy to necessary anaesthesia Intention of significant weight loss or weight gain within the trial period

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Triple blinded, randomized, paired study on healthy participants
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Scaffold and adipose-derived stromal cell enriched fat grafts<br>Randomized and paired injections. Each participant will receive all 11 solutions. | Biological: Scaffold and adipose-derived stromal cell enriched fat grafts<br>* eight different solutions of fat, ASCs, scaffold and CO2 laser in dermis three different solutions of fat, ASCs and scaffold in the subcutaneous layer<br>|
| No Intervention: Controls samples<br>Control samples of untreated skin | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume assessment | CT scan | Baseline, three months, Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cell count, immunohistochemistry, skin quality | Cell count, immunohistochemistry, skin quality | Three months, six months | 
| Immunohistochemistry | Immunohistochemistry | Three months, six months | 
| Skin thickness | Skin thickness | Three months, six months |