Cosmetic Fat Transplantation Using Expanded ASC Enriched Fat Grafts

Stemform

Status and phase: Completed; Phase 3

Conditions: Breast Hypoplasia and Facial Ageing

Treatments: Biological: ASC enriched lipofilling; Biological: Standard Lipofilling

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03258164

H-16046960

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups

ASC

Experimental group

Treatment:

Biological: ASC enriched lipofilling

Control

Active Comparator group

Treatment:

Biological: Standard Lipofilling