Clinical trial NCT03258164: Cosmetic Fat Transplantation Using Expanded ASC Enriched Fat Grafts
Official title: Fat Transplantation Enriched With Expanded Adipose-derived Autologous Mesenchymal Stromal Cells in Cosmetic Breast Augmentation and Cosmetic Facial Filling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Hypoplasia and Facial Ageing
Lead sponsor: Stemform
Sponsor class: INDUSTRY
Collaborators: name: Aleris-Hamlet Hospitaler København
First posted: 2017-08-23
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

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

Primary outcomes:
measure: Change in volume over time after breast augmentation
timeFrame: Baseline, four and twelve months
Secondary outcomes:
measure: Change in cosmetic facial appearance over time after facial filling
timeFrame: Baseline, one, four and twelve months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Stemform
state: Søborg
Study officials:
affiliation: Stemform
name: Stig-Frederik T Kølle, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: