Breast Hypoplasia and Facial Ageing Clinical Trial
Official title:
Fat Transplantation Enriched With Expanded Adipose-derived Autologous Mesenchymal Stromal Cells in Cosmetic Breast Augmentation and Cosmetic Facial Filling
| Verified date | November 2022 |
| Source | Stemform |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 32 |
| Est. completion date | November 22, 2022 |
| Est. primary completion date | October 24, 2022 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 65 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Stemform | Copenhagen | Søborg |
| Lead Sponsor | Collaborator |
|---|---|
| Stemform | Aleris-Hamlet Hospitaler København |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 |