TY - JOUR

T1 - Fat Grafting With Expanded Adipose-Derived Stromal Cells for Breast Augmentation

T2 - A Randomized Controlled Trial

AU - Vester-glowinski, Peter V

AU - Herly, Mikkel

AU - Ørholt, Mathias

AU - Rasmussen, Bo S

AU - Müller, Felix C

AU - Elberg, Jens J

AU - Thomsen, Carsten

AU - Drzewiecki, Krzysztof T

PY - 2022

Y1 - 2022

N2 - BackgroundThe main challenge with fat grafting is loss of some of the graft to postsurgery resorption. Previous studies suggest that adipose-derived stromal cells (ASCs) can improve the volume retention of fat grafts but there is a lack of randomized trials to support the use of ASCs in clinical practice.ObjectivesThis trial aimed to investigate whether ASCs improve fat graft volume retention in patients undergoing breast augmentation with lipofilling.MethodsThis was a double-blind, randomized controlled trial of breast augmentation with ASC-enriched fat grafting. Healthy women aged 30 to 45 years were enrolled. First, the participants underwent liposuction to obtain fat for culture expansion of ASCs. Then, the participants were randomly assigned to undergo a 300- to 350-mL breast augmentation with ASC-enriched fat grafting (10 × 106 ASCs/mL fat graft) to 1 of their breasts and placebo-enriched fat grafting of identical volume to the contralateral breast. The primary outcome was fat graft volume retention after a 1-year follow-up measured with MRI. The trial is registered at www.clinicaltrialsregister.eu (EudraCT-2014-000510-59).ResultsTen participants were included in the trial; all completed the treatment and follow-up. No serious adverse events occurred. Fat graft volume retention after 1 year was 54.0% (95% CI, 30.4%-77.6%) in the breasts treated with ASC-enriched fat grafting (n = 10) and 55.9% (95% CI, 28.9%-82.9%) in the contralateral breasts treated with placebo-enriched fat grafting (n = 10) (P = 0.566).ConclusionsThe findings of this trial do not support that ASC-enriched fat grafting is superior to standard fat grafting for breast augmentation.Level of Evidence: 2

AB - BackgroundThe main challenge with fat grafting is loss of some of the graft to postsurgery resorption. Previous studies suggest that adipose-derived stromal cells (ASCs) can improve the volume retention of fat grafts but there is a lack of randomized trials to support the use of ASCs in clinical practice.ObjectivesThis trial aimed to investigate whether ASCs improve fat graft volume retention in patients undergoing breast augmentation with lipofilling.MethodsThis was a double-blind, randomized controlled trial of breast augmentation with ASC-enriched fat grafting. Healthy women aged 30 to 45 years were enrolled. First, the participants underwent liposuction to obtain fat for culture expansion of ASCs. Then, the participants were randomly assigned to undergo a 300- to 350-mL breast augmentation with ASC-enriched fat grafting (10 × 106 ASCs/mL fat graft) to 1 of their breasts and placebo-enriched fat grafting of identical volume to the contralateral breast. The primary outcome was fat graft volume retention after a 1-year follow-up measured with MRI. The trial is registered at www.clinicaltrialsregister.eu (EudraCT-2014-000510-59).ResultsTen participants were included in the trial; all completed the treatment and follow-up. No serious adverse events occurred. Fat graft volume retention after 1 year was 54.0% (95% CI, 30.4%-77.6%) in the breasts treated with ASC-enriched fat grafting (n = 10) and 55.9% (95% CI, 28.9%-82.9%) in the contralateral breasts treated with placebo-enriched fat grafting (n = 10) (P = 0.566).ConclusionsThe findings of this trial do not support that ASC-enriched fat grafting is superior to standard fat grafting for breast augmentation.Level of Evidence: 2

U2 - 10.1093/asj/sjac159

DO - 10.1093/asj/sjac159

M3 - Journal article

C2 - 35704475

VL - 42

SP - 1279

EP - 1289

JO - Aesthetic Surgery Journal

JF - Aesthetic Surgery Journal

SN - 1090-820X

IS - 11

ER -