Cosmetic Fat Transplantation Using Expanded ASC Enriched Fat Grafts

Study Overview
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Brief Summary
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The purpose of the present study is to examine whether enrichment of a fat graft with autologous ex vivo expanded ASC injected into the breast tissue or face, both for cosmetic use, will significantly improve the results of conventional lipofilling and synthetic facial fillers, thereby being able to offer a safer, more natural and long-lasting alternative to current artificial solutions for cosmetic patients.

Detailed Description
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The cosmetic breast augmentation design is a double-blind (surgeon and data assessor) randomized, prospective clinical study on healthy subjects. The cosmetic facial filling design is a data assessor-blinded, randomized, prospective clinical study on healthy subjects.

Official Title
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Fat Transplantation Enriched With Expanded Adipose-derived Autologous Mesenchymal Stromal Cells in Cosmetic Breast Augmentation and Cosmetic Facial Filling

Conditions
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Breast Hypoplasia and Facial Ageing

Intervention / Treatment
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* Biological: ASC enriched lipofilling
* Biological: Standard Lipofilling


Participation Criteria
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Eligibility Criteria
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Criteria breast augmentation: Inclusion criteria Age 18 - 50 years Healthy females BMI 18 - 30 kg/m2 1000 ml of fat (lipoaspirate) available for liposuction at the abdomen and/or thighs Desire for breast augmentation Speaks and reads Danish or English Signed informed consent Exclusion criteria Smoking Previous breast surgery Previous cancer or predisposition to breast cancer Pregnancy or planned pregnancy within one year after the procedure Breastfeeding less than 6 months prior to inclusion Weight gain or loss above 2 BMI point Known chronic disease associated with metabolism malfunction or pour healing Pacemaker or other implanted foreign objects Allergy towards necessary anaesthesia Intention of weight loss or weight gain within the trial period Criteria fascial filling Inclusion criteria Age 25 - 65 years Healthy females BMI 18 - 30 kg/m2 100 ml of fat (lipoaspirate) available for liposuction at the abdomen and/or thighs Desire for facial wrinkle treatment and facial augmentation (rejuvenation) Speaks and reads Danish or English Signed informed consent Exclusion criteria Smoking Previous facial surgery Previous cancer Pregnancy or planned pregnancy within one year after the procedure Known chronic disease associated with metabolism malfunction or poor healing Allergy towards necessary anaesthesia Intention of weight loss or weight gain within the trial period

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASC<br> | Biological: ASC enriched lipofilling<br>* Fat grafts enriched with ex vivo expanded ASC<br>|
| Active Comparator: Control<br> | Biological: Standard Lipofilling<br>* Non-ASC enriched fat grafts<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in volume over time after breast augmentation | Measurement of the residual volume of fat transplants as based on MRI before operation (baseline), and four and twelve months after lipo-injection to the breast in order to determine the difference in volume between baseline and 4 months and 12 months post operative; and thereby the resorption rate over time. | Baseline, four and twelve months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cosmetic facial appearance over time after facial filling | Assessment of cosmetic outcome based on clinical photos before (baseline), one, four and twelve months after the procedure when compared to baseline, evaluated by 5 independent plastic surgeons blinded to the intervention using a scale of 1-5 to determine the difference in appearance over time. | Baseline, one, four and twelve months |