OBJECTIVE: This study reports outcomes for the first twenty-two patients undergoing breast augmentation (Stemform BA) or artificial implant replacement (Stemform AIR) with MSC(AT)-enriched fat in a real-world setting.
METHODS: Autologous MSC(AT)s were isolated and expanded ex vivo, then mixed with lipoaspirate and injected as enriched fat for Stemform BA and AIR. The breast volume was measured preoperatively and at 3 and 12 months postoperative using a 3D Infinity Dual-Lens Camera and LifeVizApp software. Additionally, independent plastic surgeons evaluated clinical images, and patient satisfaction was obtained at equal time points.
RESULTS: Twenty-two patients were included. All completed 3 and 12 months clinical follow-up and 3 months volume measurements. Nineteen patients completed 12 months volume measurements. The median fat graft retention at 12 months was 95.7% (IQR = 82.44-103.12%) for Stemform BA patients and 113.0% (IQR = 94.8-131.2%) for Stemform AIR patients. The Stemform BA patients had a median breast enlargement of 172.0% (IQR = 156.7-241.0%). The implant replacement volume of Stemform AIR patients was 102% (IQR = 85.1-130.3%). The patient reported 92.8% and 100% would elect to repeat treatment if they had the opportunity for Stemform BA and Stemform AIR, respectively.
CONCLUSIONS: Breast augmentation and breast implant replacement patients receiving ex vivo-expanded MSC(AT)-enriched fat grafts had high graft retention and patient satisfaction scores. The paper confirms the clinical efficacy of using ex vivo-expanded MSC(AT)s. Level of Evidence V This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
目的:本研究报告了在真实世界环境中使用富含MSC(AT)的脂肪进行隆胸(StemformBA)或人工植入物置换(StemformAIR)的前22例患者的结果。
方法:分离并体外扩增自体MSC(AT),然后与脂肪抽吸物混合,并作为富含脂肪的STemformBA和AIR注射。使用3DInfinity双镜头相机和LifeVizApp软件在术前和术后3和12个月测量乳房体积。此外,独立的整形外科医生评估临床图像,在相同的时间点获得患者满意度。
结果:包括22例患者。全部完成3个月和12个月的临床随访和3个月的体积测量。19名患者完成了12个月的体积测量。StemformBA患者12个月的中位脂肪移植物保留率为95.7%(IQR=82.44-103.12%),StemformAIR患者为113.0%(IQR=94.8-131.2%)。StemformBA患者的中位乳房增大为172.0%(IQR=156.7-241.0%)。StemformAIR患者的植入物置换体积为102%(IQR=85.1-130.3%)。患者报告92.8%和100%会选择重复治疗,如果他们有机会使用StemformBA和StemformAIR,分别。
结论:隆胸和乳房植入物置换患者接受离体扩增的富含MSC(AT)的脂肪移植有较高的移植物保留率和患者满意度评分。本文证实了使用离体扩增的MSC(AT)的临床疗效。证据级别V本期刊要求作者为每篇文章分配一个级别的证据。对于这些循证医学评级的完整描述,请参阅目录或在线作者说明www。springer.com/00266.