Mayhew T A, Williams G R, Senica M A, Kuniholm G, Du Moulin G C
Departments of Quality Systems and Manufacturing, Genzyme Tissue Repair, Cambridge, Massachusetts 02139-4136, USA.
Tissue Eng. 1998 Fall;4(3):325-34. doi: 10.1089/ten.1998.4.325.
The use of living human cells to facilitate repair of defects in structural tissues is a rapidly emerging treatment option. A quality assurance program based on U.S. Food and Drug Administration good manufacturing practice regulations and other guidance was established and implemented in a program to use autologous cultured chondrocytes for repair of articular defects of the knee. The development of ex vivo cell therapies presents novel issues of quality assurance. The implementation and evaluation of this quality program was based on the implantation of 303 patients with autologous cultured chondrocytes, in which we analyzed a number of quantifiable parameters and which meets the unique challenges of autologous cell therapy within a rigorous regulatory framework. Application of well-accepted principles of quality assurance and quality control coupled with a thorough understanding of the cell culturing processes will result in a safe and efficacious cell therapy product.
利用活的人体细胞促进结构组织缺损的修复是一种迅速兴起的治疗选择。在一项使用自体培养软骨细胞修复膝关节软骨缺损的项目中，建立并实施了一项基于美国食品药品监督管理局良好生产规范法规及其他指南的质量保证计划。体外细胞疗法的发展带来了质量保证方面的新问题。该质量计划的实施和评估基于303例接受自体培养软骨细胞植入的患者，在此过程中我们分析了许多可量化参数，并且该计划在严格的监管框架内应对了自体细胞疗法的独特挑战。应用公认的质量保证和质量控制原则并深入了解细胞培养过程，将产生安全有效的细胞治疗产品。
