临床级人胎盘源多能间充质基质细胞的制造

Manufacture of clinical grade human placenta-derived multipotent mesenchymal stromal cells.

作者信息

Ilic Nina, Brooke Gary, Murray Patricia, Barlow Sarah, Rossetti Tony, Pelekanos Rebecca, Hancock Sonia, Atkinson Kerry

机构信息

Mater Health Services, Brisbane, Queensland, 4101, Australia.

出版信息

Methods Mol Biol. 2011;698:89-106. doi: 10.1007/978-1-60761-999-4_8.

DOI:10.1007/978-1-60761-999-4_8

PMID:21431513

Abstract

Clinical grade human mesenchymal stem cells (MSC) are manufactured and used in clinical trials for a range of regenerative and inflammatory diseases. Human MSC have now been derived from tissues other than bone marrow, such as placenta, as described in this laboratory protocol. It provides instructions for clinical grade MSC manufacturing according to the Code of Good Manufacturing Practice (cGMP) principles and according to policies and procedures of our internal Quality Management System (QMS), which is based on the International Organization for Standardization (ISO) standard requirements. Relevant organizational structure and QMS elements are presented.

摘要

临床级人骨髓间充质干细胞（MSC）被制造出来并用于一系列再生性和炎症性疾病的临床试验。如本实验室方案所述，人MSC现已从骨髓以外的组织中获取，如胎盘。它根据良好生产规范（cGMP）原则以及我们基于国际标准化组织（ISO）标准要求的内部质量管理体系（QMS）的政策和程序，提供临床级MSC制造的指导说明。文中还介绍了相关的组织结构和QMS要素。