Enrichment of autologous fat grafts with ex-vivo expanded adipose tissue-derived stem cells for graft survival: a randomised placebo-controlled trial
Enrichment of autologous fat grafts with ex-vivo expanded adipose tissue-derived stem cells for graft survival: a randomised placebo-controlled trial
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DOI：
10.1016/s0140-6736(13)61410-5
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发表时间：
2013-09-28
期刊：
影响因子：
168.9
通讯作者：
Drzewiecki, Krzysztof Tadeusz
中科院分区：
文献类型：
--
作者：
Kolle, Stig-Frederik Trojahn;Fischer-Nielsen, Anne;Drzewiecki, Krzysztof Tadeusz
背景：自体脂肪移植在重建外科中的应用越来越广泛。然而，据报道，吸收率从25%到80%不等。因此，提高移植物存活率的方法是必要的。在这里，我们报道了一项三盲、安慰剂对照试验的结果，以比较富含自体脂肪来源干细胞(ASCs)的脂肪移植物和未富含脂肪移植物的存活率。方法健康受试者接受了两次相隔14天的吸脂手术：一次是ASC分离和体外扩张，另一次是脂肪移植物的制备。从第二次吸脂中取出两个纯化的脂肪移植物(每个30毫升)，为每个参与者准备。其中一组移植物中加入ASCs(每毫升脂肪20×106个细胞)，另一组不加ASC作为对照。根据随机序列，将脂肪移植物作为推注注射到右上臂和左上臂的后部。分别于注射后即刻和手术前121天用MRI测量注射脂肪的体积。主要目的是比较富含ASC的移植物与对照移植物的残余移植物体积。这项研究已在WWW上注册。临床试验登记。欧盟，编号2010-023006-12。调查结果13名参与者，其中3名被排除在外。与对照组相比，ASC强化脂肪移植物的残余体积显著增加，分别为23.00(95%CI 20.57~25.43)cm3和4.66(3.16~6.16)cm3，分别相当于初始体积的80.9%(76.6~85.2)和16.3%(11.1~21.4)(p<；0.0001)。两组间的差值为18.34(95%可信区间15.70~20.98)cm3，相当于64.6%(57.1~72.1；p<；0.0001)。无严重不良事件发生，说明ASC强化脂肪移植具有良好的可行性和安全性。这些有希望的结果大大增加了干细胞在临床环境中的应用前景，并表明ASC移植物浓缩可以使脂肪脂肪成为替代主要组织增强术的可靠选择，例如使用同种异体材料的乳房手术或大型FAP手术。
Background Autologous fat grafting is increasingly used in reconstructive surgery. However, resorption rates ranging from 25% to 80% have been reported. Therefore, methods to increase graft viability are needed. Here, we report the results of a triple-blind, placebo-controlled trial to compare the survival of fat grafts enriched with autologous adiposederived stem cells (ASCs) versus non-enriched fat grafts.Methods Healthy participants underwent two liposuctions taken 14 days apart: one for ASC isolation and ex-vivo expansion, and another for the preparation of fat grafts. Two purifi ed fat grafts (30 mL each) taken from the second liposuction were prepared for each participant. One graft was enriched with ASCs (20 x 106 cells per mL fat), and another graft without ASC enrichment served as a control. The fat grafts were injected subcutaneously as a bolus to the posterior part of the right and left upper arm according to the randomisation sequence. The volumes of injected fat grafts were measured by MRI immediately after injection and after 121 days before surgical removal. The primary goal was to compare the residual graft volumes of ASC-enriched grafts with those of control grafts. This study is registered at www. clinicaltrialsregister. eu, number 2010-023006-12.Findings 13 participants were enrolled, three of whom were excluded. Compared with the control grafts, the ASCenriched fat grafts had signifi cantly higher residual volumes: 23.00 (95% CI 20.57-25.43) cm 3 versus 4.66 (3.16-6.16) cm 3 for the controls, corresponding to 80.9% (76.6-85.2) versus 16.3% (11.1-21.4) of the initial volumes, respectively (p< 0.0001). The diff erence between the groups was 18.34 (95% CI 15.70-20.98) cm 3, equivalent to 64.6% (57.1-72.1; p< 0.0001). No serious adverse events were noted.Interpretation The procedure of ASC-enriched fat grafting had excellent feasibility and safety. These promising results add signifi cantly to the prospect of stem cell use in clinical settings, and indicate that ASC graft enrichment could render lipofi lling a reliable alternative to major tissue augmentation, such as breast surgery, with allogeneic material or major fl ap surgery.