Cosmetic Fat Transplantation Using Expanded ASC Enriched Fat Grafts

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Hypoplasia and Facial Ageing
• Intervention / Treatment: Biological: ASC enriched lipofilling; Biological: Standard Lipofilling

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Søborg
    • Copenhagen, Søborg, Denmark, 2860
      • Stemform

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control	Biological: Standard Lipofilling; Non-ASC enriched fat grafts
EXPERIMENTAL: ASC	Biological: ASC enriched lipofilling; Fat grafts enriched with ex vivo expanded ASC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Stemform
• Collaborators: Aleris-Hamlet Hospitaler København
• Investigators: Principal Investigator: Stig-Frederik T Kølle, MD, PhD, Stemform

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 22, 2017
• Primary Completion (ACTUAL): October 24, 2022
• Study Completion (ACTUAL): November 22, 2022

Study Registration Dates

• First Submitted: August 7, 2017
• First Submitted That Met QC Criteria: August 18, 2017
• First Posted (ACTUAL): August 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 28, 2022
• Last Update Submitted That Met QC Criteria: November 24, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Facies
• Other Study ID Numbers: H-16046960

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Results will be published in international medical journals

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No