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干细胞药物产业化研究进展及存在问题

Research progress and existing problems in the industrialization of stem cell drugs

  • 摘要: 干细胞是一类具有多向分化潜能和自我更新能力的原始未分化细胞,有再生人体各种组织和器官的潜在功能。干细胞药物开发是生命科学的前沿研究领域。干细胞在不同重大疑难性疾病的治疗上开展了广泛的临床试验,在某些适应证上作为药物获得批准上市,有着广阔的产业化前景。本综述通过介绍干细胞药物在全球及国内产业化方面的进展,及产业化存在的主要问题,如干细胞药物的有效性、质量控制、安全性等,为干细胞药物的开发提供参考和思路,以加快干细胞药物的产业化进程。

     

    Abstract: Stem cells, which are a type of primitive cells with multipotent differentiation potential and self-renewal ability, have the potential to regenerate various tissues and organs. Stem cell drug development is a frontier research field in life sciences. Extensive clinical trials involving stem cells have been conducted for different complicated diseases. Some stem cells have been approved as drugs for some indications, indicating their broad industrial prospects. This review introduces the progress of stem cell drugs around the world, especially in China, and discusses the main problems in the industrialization of stem cell drugs, such as their effectiveness, quality control and safety, so as to provide some reference and insight for the development and rapid industrialization of stem cell drugs.

     

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