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目的对近年来国内外有关脂肪源性干细胞(adipose-derived stem cells,ASCs)在临床转化应用中应该或必须关注的问题进行综述。方法广泛查阅近年相关文献,对ASCs生产和使用过程中有关产品的管理、生产、运输、使用、安全性等方面进行综合分析。结果 ASCs作为成体干细胞家族的新成员在再生医学领域展现了广阔的应用前景。目前在美国国立卫生研究院(NIH)的http://www.clinicaltrials.gov网站上已注册登记的在15个国家进行的临床试验达40多个,说明世界范围内从事干细胞研究和应用的学者对ASCs临床转化应用的浓厚兴趣和重视。在临床转化应用中,ASCs产品存在管理,生产应遵循的质量控制标准,病原微生物污染的预防措施,分离过程中对酶和相关试剂的要求,取材过程中供区、年龄和性别可能的影响,低温贮藏,产品运输以及安全性等一系列问题。结论 ASCs作为成体干细胞具有较好的临床转化应用优点,在临床应用中对其存在的问题必须给予高度重视和进一步研究,以加速其临床转化过程。
OBJECTIVE: To summarize the questions that should be or must be paid attention to in the clinical application of adipose-derived stem cells (ASCs) both at home and abroad in recent years. Methods Extensively consult related literatures in recent years and make a comprehensive analysis of management, production, transportation, use and safety of the related products in the process of production and use of ASCs. Results As a new member of adult stem cell family, ASCs have shown broad application prospects in the field of regenerative medicine. More than 40 clinical trials currently conducted at the National Institutes of Health (NIH) http://www.clinicaltrials.gov site have been conducted in 15 countries, indicating that scholars worldwide engaged in stem cell research and applications Strong interest in and attention to the clinical application of ASCs. In the clinical application of transformation, there are quality control standards to be followed in the management of ASCs products, prevention of pathogenic microorganism contamination, requirements for enzymes and related reagents in the separation process, possible supply areas, age and sex in the process of material extraction, Cryogenic storage, product transport and safety and a series of issues. Conclusion ASCs as adult stem cells have the advantages of clinical application of transformation. In the clinical application, ASCs should be given high priority and further study to speed up their clinical transformation process.