间充质干细胞基础研究与临床转化的中美比较

目的：从基础研究、专利申请、临床试验角度对比分析中美间充质干细胞领域发展现状和趋势,了解中美间充质干细胞领域研究的主要特征,为中国间充质干细胞领域的发展提供建议。方法：检索SCI论文数据、DII专利数据及Clinical Trials临床试验数据及新药审批情况,利用Excel、DDA工具对检索结果进行定量分析和讨论。结果：中国在间充质干细胞基础研究、专利申请及临床试验方面虽起步较晚,但近年来发展迅速,论文、专利和临床试验数量快速增长,2014年起发表论文数量及2016年申请专利数量均超过美国,临床试验注册已达200余项;在骨质疏松、脊髓损伤等研究领域,内分泌系统疾病、自体免疫疾病等临床试验方面形成一定优势,已具备坚实的团队与技术基础。但我国间充质干细胞研究仍面临激烈的竞争,存在进步与发展空间。结论：我国间充质干细胞研究应发挥已有优势,加强战略性布局;重视发展以企业为主导的新药开发路径;做精做细以增强国际竞争力与影响力;加大资金投入和产业政策的支持;健全监管机制及评价体系,抓住机遇的同时积极迎接挑战。

Comparison of Research and Clinical Transformation on Mesenchymal Stem Cells between China and the US

Objective: Compare the development status and trends of mesenchymal stem cells (MSCs) in basic research, patent application and clinical trial registration between China and the US. Find out the main characteristics of MSCs research in these two countries and provide suggestions for Chinese MSCs development. Methods: The paper data in SCI database, the patent data in DII database and the clinical trial data in Clinical Trials database are retrieved. The quantitative analysis is carried out by Excel and DDA. SWOT analysis is used to discuss the advantages and disadvantages, opportunities and threats of Chinese MSCs development. Results: Although China started late on MSCs research, it has developed rapidly in recent years. The number of papers since 2014 and patent applications in 2016 exceeds that of the United States, and the number of clinical trials has reached more than 200. China has advantages in the research fields of osteoporosis and spinal cord injury and some clinical trials such as endocrine system diseases and autoimmune diseases. However, there is still room for improvement in the study of MSCs in China. Conclusion: China should give full play to its existing advantages and strengthen the strategic layout; attach importance to the enterprise-led new drug development path; make efforts to enhance its international competitiveness and influence; increase capital investment and support of industrial policies and improve the regulatory mechanism and evaluation system.