Breast Hypoplasia and Facial Ageing
Conditions
Brief summary
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
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.
Interventions
BIOLOGICALASC enriched lipofilling
Fat grafts enriched with ex vivo expanded ASC
BIOLOGICALStandard Lipofilling
Non-ASC enriched fat grafts
Sponsors
Aleris-Hamlet Hospitaler København
Stemform
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in volume over time after breast augmentation | Baseline, four and twelve months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in cosmetic facial appearance over time after facial filling | Baseline, one, four and twelve months | 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. |
Countries
Denmark
Outcome results
None listed