神经修复临床细胞治疗现状与展望

Current status and prospect of cell therapy in neurorestoration

细胞治疗作为21世纪新的临床医疗技术已成为世界医学界共识,美国药监局将细胞治疗产品分为干细胞治疗产品和成熟/功能分化细胞治疗产品两大类。我国细胞治疗学界对这两类细胞产品尚无清晰的概念定义和确定二者的界限,有些人把国际细胞治疗学会制定的间充质基质细胞鉴定标准作为间充质干细胞鉴定标准,干扰了国家相关部委制定的细胞治疗政策、法规和管理,影响我国细胞治疗的健康发展。从神经修复细胞治疗开展时间和持续时间、发表文章及报告病例数、治疗效果和在专业领域影响力几方面看,我国在这一领域临床细胞治疗水平目前处于世界前沿。细胞学界应清晰定义干细胞和成熟/功能分化细胞治疗产品的概念并确定二者的界限,只有这样国家相关政府部门才能制定出边界清晰的细胞治疗产品管理法规,此是我国临床细胞治疗创新必须具备的法律法规保证。

Cell therapy as a new medical technology in the 21st century has become the consensus of medical community in the world. The US Food and Drug Administration divides cell therapy products into stem cell-derived cell therapy products and mature/functionally differentiated cell-derived cell therapy products. Cell therapy community in China has not clearly defined these two kinds of cell therapy products. One serious issue is that cell therapy community in China misuses the identification standards of mesenchymal stromal cell established by International Society of Cellular Therapy as the identification standard of mesenchymal stem cell, which has led to wrong policy, regulation and administration of cell therapy from the relevant government ministries, and hinder the development of cell therapy in China. In terms of the long history of clinical cell therapy of neruorestoration, published papers, number of treated patients, treatment outcome and impact in professional field, China is currently in the forefront of the world in the clinical cell therapy of neurorestoration. Only the academic community of cell therapy defines the clear concept of both stem cell therapy products and mature/fimctionally differentiated cell therapy products and determines their boundaries, and related government ministries may develop laws and regulations with a clear boundary between two kinds of cell therapy products, which can promote clinical cell therapy innovation in Cina.