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

H-16046960

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.

2017-03-22

2022-10-24

2022-11-22

Completed

Early phase I

32

Criteria breast augmentation: Inclusion criteria 1. Age 18 - 50 years 2. Healthy females 3. BMI 18 - 30 kg/m2 4. 1000 ml of fat (lipoaspirate) available for liposuction at the abdomen and/or thighs 5. Desire for breast augmentation 6. Speaks and reads Danish or English 7. Signed informed consent Exclusion criteria 1. Smoking 2. Previous breast surgery 3. Previous cancer or predisposition to breast cancer 4. Pregnancy or planned pregnancy within one year after the procedure 5. Breastfeeding less than 6 months prior to inclusion 6. Weight gain or loss above 2 BMI point 7. Known chronic disease associated with metabolism malfunction or pour healing 8. Pacemaker or other implanted foreign objects 9. Allergy towards necessary anaesthesia 10. Intention of weight loss or weight gain within the trial period Criteria fascial filling Inclusion criteria 1. Age 25 - 65 years 2. Healthy females 3. BMI 18 - 30 kg/m2 4. 100 ml of fat (lipoaspirate) available for liposuction at the abdomen and/or thighs 5. Desire for facial wrinkle treatment and facial augmentation (rejuvenation) 6. Speaks and reads Danish or English 7. Signed informed consent Exclusion criteria 1. Smoking 2. Previous facial surgery 3. Previous cancer 4. Pregnancy or planned pregnancy within one year after the procedure 5. Known chronic disease associated with metabolism malfunction or poor healing 6. Allergy towards necessary anaesthesia 7. Intention of weight loss or weight gain within the trial period

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2022-11-28