脂肪来源干细胞的非标签使用。
Off-label use of adipose-derived stem cells.
作者信息
Simonacci Francesco, Bertozzi Nicolò, Raposio Edoardo
机构信息
Department of Medicine and Surgery, Plastic Surgery Division, University of Parma, Parma, Italy.
The Cutaneous, Mininvasive, Regenerative and Plastic Surgery Unit, Parma University Hospital, Parma, Italy.
出版信息
Ann Med Surg (Lond). 2017 Oct 25;24:44-51. doi: 10.1016/j.amsu.2017.10.023. eCollection 2017 Dec.
BACKGROUND
Adipose-derived stem cells (ASCs) have a broad range of clinical applications. The ease of cell harvest and high yield with minimal donor-site morbidity makes adipose tissue an ideal source of stem cells. Further, the multi-lineage potential of these cells present significant opportunities within the field of tissue engineering, with studies successfully demonstrating their ability to produce a range of tissue types.
MATERIALS AND METHODS
Literature review of publications on the use of ASCs, in the context of current European and US regulations.
RESULTS
According to European and US regulations, many clinical trials reported in literature to date could be considered off-label.
CONCLUSION
In Europe, clinical trials involving cultured ASCs and/or the use of collagenase, which causes changes in the structural and functional properties of stem cells, and/or ASCs application in non-homologous tissue, should be considered off-label. ASCs should be non-cultured, isolated mechanically, and used only in the subcutaneous tissue.
背景
脂肪来源干细胞（ASCs）具有广泛的临床应用。细胞采集简便、产量高且供区发病率极低，使得脂肪组织成为理想的干细胞来源。此外，这些细胞的多向分化潜能在组织工程领域提供了重大机遇，多项研究已成功证明它们能够生成一系列组织类型。
材料与方法
依据当前欧洲和美国法规，对有关ASCs应用的文献进行综述。
结果
根据欧洲和美国法规，迄今为止文献中报道的许多临床试验可能被视为超说明书用药。
结论
在欧洲，涉及培养的ASCs和/或使用胶原酶（其会导致干细胞结构和功能特性发生变化）以及/或者将ASCs应用于非同源组织的临床试验，应被视为超说明书用药。ASCs应未经培养、通过机械方法分离，且仅用于皮下组织。
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