Department of Plastic Surgery and Burns, Copenhagen University Hospital, Copenhagen, Denmark.
Department of Immunology and Microbiology, University of Copenhagen, Copenhagen, Denmark.
Aesthet Surg J. 2022 Oct 13;42(11):1279-1289. doi: 10.1093/asj/sjac159.
The 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.
This trial aimed to investigate whether ASCs improve fat graft volume retention in patients undergoing breast augmentation with lipofilling.
This 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).
Ten 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).
The findings of this trial do not support that ASC-enriched fat grafting is superior to standard fat grafting for breast augmentation.
脂肪移植的主要挑战是术后吸收导致部分移植物丢失。先前的研究表明脂肪来源的基质细胞（ASCs）可以提高脂肪移植物的体积保留率，但缺乏随机试验来支持在临床实践中使用 ASCs。
本试验旨在研究 ASCs 是否能改善接受脂肪填充隆乳术患者的脂肪移植物体积保留率。
这是一项 ASC 富集脂肪移植隆乳的双盲、随机对照试验。纳入年龄在 30 岁至 45 岁之间的健康女性。首先，参与者接受吸脂术以获取脂肪，用于 ASC 的培养扩增。然后，参与者被随机分配到一侧乳房接受 ASC 富集脂肪移植（每毫升脂肪移植 10×106 ASCs），另一侧乳房接受等量安慰剂富集脂肪移植。主要结局是通过 MRI 测量 1 年后脂肪移植物体积保留率。该试验在 www.clinicaltrialsregister.eu（EudraCT-2014-000510-59）注册。
本试验纳入了 10 名参与者，均完成了治疗和随访。未发生严重不良事件。接受 ASC 富集脂肪移植治疗的乳房 1 年后脂肪移植物体积保留率为 54.0%（95%CI，30.4%-77.6%）（n=10），接受安慰剂富集脂肪移植治疗的对侧乳房为 55.9%（95%CI，28.9%-82.9%）（n=10）（P=0.566）。
本试验结果不支持 ASC 富集脂肪移植优于标准脂肪移植用于隆乳。
