Grabin Soraya, Antes Gerd, Stark G Björn, Motschall Edith, Buroh Sabine, Lampert Florian M
Department of Plastic Surgery, University Medical Center Freiburg, German Cochrane Centre, University Medical Center Freiburg, Center for Medical Biometry and Medical Informatics, University of Freiburg, Department of General and Visceral Surgery, University Medical Center Freiburg.
Dtsch Arztebl Int. 2015 Apr 10;112(15):255-61. doi: 10.3238/arztebl.2015.0255.
Because of their easy accessibility and versatile biological properties, mesenchymal stem cells taken from fatty tissue (adipose-derived stem cells, ADSC) are attractive for various potential clinical uses. For example, ADSC can be added to fatty tissue before transplantation in the hope of improving the outcome of autologous lipotransfer: the modified procedure is called cell-assisted lipotransfer. The clinical use and commercial promotion of this novel stem-cell treatment (and others) are spreading rapidly, even though there is not yet any clear clinical evidence for its safety and efficacy.
In cooperation with the German Cochrane Center, we systematically searched the literature according to the PRISMA criteria. Eight major medical databases were searched. The retrieved publications were examined by two independent reviewers and assessed using objective criteria.
After screening of the 3161 retrieved publications by title, abstract, and (where appropriate) full text, 78 were still considered relevant. 13 of these were reports of clinical studies; only 3 of the 13 met criteria for grade II or III evidence. The studies that were analyzed involved a total of 286 cell-assisted lipotransfer procedures with a longest follow-up time of 42 months. Oncological safety was not demonstrated.
The studies published to date have not shown that cell-assisted lipotransfer is generally superior to conventional autologous lipotransfer. They dealt with safety aspects inappropriately or not at all. The case of cell-assisted lipotransfer illustrates the indispensability of high-quality clinical evidence before the introduction of novel stem-cell-based treatments.
由于其易于获取且具有多种生物学特性,取自脂肪组织的间充质干细胞(脂肪来源干细胞,ADSC)在各种潜在临床应用中具有吸引力。例如,ADSC可在自体脂肪移植前添加到脂肪组织中,以期改善自体脂肪移植的效果:这种改良方法称为细胞辅助脂肪移植。尽管尚无明确的临床证据证明这种新型干细胞治疗(以及其他治疗)的安全性和有效性,但其临床应用和商业推广正在迅速蔓延。
我们与德国科克伦中心合作,根据PRISMA标准系统检索文献。检索了八个主要医学数据库。检索到的出版物由两名独立评审员进行审查,并使用客观标准进行评估。
在对检索到的3161篇出版物进行标题、摘要和(如适用)全文筛选后,仍有78篇被认为相关。其中13篇为临床研究报告;13篇中只有3篇符合二级或三级证据标准。所分析的研究总共涉及286例细胞辅助脂肪移植手术,最长随访时间为42个月。未证明其肿瘤学安全性。
迄今为止发表的研究并未表明细胞辅助脂肪移植总体上优于传统的自体脂肪移植。它们对安全性方面的处理不当或根本未涉及。细胞辅助脂肪移植的案例说明了在引入基于干细胞的新型治疗方法之前高质量临床证据的不可或缺性。