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Ex vivo-expanded autologous adipose tissue-derived stromal cells ensure enhanced fat graft retention in breast augmentation: A randomized controlled clinical trial.
STEM CELLS Translational Medicine ( IF 6 ) Pub Date : 2020-07-08 , DOI: 10.1002/sctm.20-0081
Stig-Frederik T Kølle 1, 2 , Dominik Duscher 3, 4 , Mikkel Taudorf 5 , Anne Fischer-Nielsen 1, 6 , Jesper D Svalgaard 1, 6 , Lea Munthe-Fog 1 , Bo Jønsson 1, 2 , Peter B Selvig 1 , Frederik P Mamsen 1, 2 , Adam J Katz 7
Affiliation  

Autologous fat grafting and implant surgery are used for volume restoration in plastic surgery. With the aim of producing a treatment superior to current solutions, we report a randomized, controlled, data assessor‐blinded clinical trial comparing fat grafts enriched with ex vivo‐expanded autologous adipose‐derived stromal cells (ASCs) to nonenriched fat grafts in breast augmentation. The intervention group received ASC‐enriched fat grafts (≥20 × 106 viable ex vivo‐expanded ASCs per milliliter fat), and the control group received conventional nonenriched fat grafts. Volume retention was measured by magnetic resonance imaging, and clinical photographs were taken simultaneously for outcome evaluation. ASC‐enriched fat grafts had significantly higher retention rates (mean = 80.2%) compared with conventional fat grafts (mean = 45.1%). Clinical photos showed statistically significant superior results in the intervention group, assessed by independent clinical experts. These results improve the prospects for using culture‐expanded ASCs in both reconstructive and cosmetic volume restoration and make the procedure an attractive alternative to conventional fat grafting and implants. This study is registered at www.ClinicalTrials.gov, number H‐16046960.

中文翻译:

体外扩增的自体脂肪组织来源的基质细胞确保在隆胸中增强脂肪移植物的保留:一项随机对照临床试验。

自体脂肪移植和植入手术用于整形手术中的体积恢复。为了提供优于当前解决方案的治疗方法,我们报告了一项随机、对照、数据评估者盲法的临床试验,该试验将富含离体扩增的自体脂肪衍生基质细胞 (ASC) 的脂肪移植物与未富集的脂肪移植物在隆胸中进行比较. 干预组接受了富含 ASC 的脂肪移植(≥20 × 10 6活体外扩增的 ASCs 每毫升脂肪),对照组接受传统的非富集脂肪移植。通过磁共振成像测量体积保留,并同时拍摄临床照片以评估结果。与传统脂肪移植物(平均值 = 45.1%)相比,富含 ASC 的脂肪移植物具有显着更高的保留率(平均值 = 80.2%)。独立临床专家评估的临床照片显示,干预组在统计学上具有显着的优越效果。这些结果改善了在重建和美容体积修复中使用培养扩增的 ASC 的前景,并使该程序成为传统脂肪移植和植入物的有吸引力的替代方案。该研究在 www.ClinicalTrials.gov 注册,编号 H-16046960。
更新日期:2020-07-08
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