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测试大介质干细胞密基因基产品用于组织再生的功效测试

Georgy Sagaradze¹, Anna Monakova^1,2, Anastasia Efimenko^1,2

¹Institute for Regenerative Medicine, Medical Research and Education Center, Lomonosov Moscow State University, 27/10, Lomonosovskiy av., 119192 Moscow, Russia.

International journal of molecular sciences

|June 10, 2023

概括

介酶体 stromal 细胞 (MSC) 秘密体可以恢复干细胞,但需要进行强度测试以进行临床转化. 本综述应用了生物和细胞治疗指南来开发这些试验,重点关注利基再生.

科学领域:

再生医学是一种再生医学.
干细胞生物学干细胞生物学
组织工程是组织工程.

背景情况:

成人干细胞依赖于特定的微环境 () 来实现恒温和再生.
利基功能障碍可能导致慢性或急性疾病,需要再生治疗.
多能介质干细胞 (MSCs) 和它们的秘密体显示出修复受损干细胞的潜力.

研究的目的:

为了解决MSC秘密产品缺乏监管指南的问题.
提出一个框架,为MSC秘密基基的再生疗法开发功效测试.
检查MSC分泌体对干细胞,特别是精子干细胞的影响.

主要方法:

对生物制剂和细胞疗法的现有指导方针进行审查.
将这些指导方针应用于MSC分泌物产品功效测试的开发.
专注于测量对干细胞利基的影响的测试.

主要成果:

由于监管方面的缺陷,特别是功效测试开发方面的缺陷,MSC分泌物产品的临床翻译受到阻碍.
现有的生物制剂和细胞疗法的指导方针可以为创建相关的功效测试提供信息.
了解MSC分泌对特定利基的作用,如精子干细胞利基,至关重要.

结论:

标准化功效测试对于MSC分泌体疗法的成功临床转化至关重要.
为了克服当前的障碍,需要采用符合法规的测试开发方法.
进一步研究MSC与多种干细胞的分泌体相互作用,将有助于治疗方面的进步.

关键词:

条件化介质是指一个条件化介质.男人的不孕不育症.它们的作用机制.介酶干细胞/介酶干细胞.强度测试试验强度测试试验质量控制质量控制质量控制再生医学是一种再生医学.一些秘密一些秘密.精子基因细胞的基因细胞利基.干细胞的利基是干细胞.翻译翻译翻译翻译翻译翻译

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