title: Manufacture of clinical grade human placenta-derived multipotent mesenchymal stromal cells.
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.
authors: Mater Health Services, Brisbane, Queensland, 4101, Australia.
authors: Nina
authors: N
authors: Ilic
authors: Gary
authors: G
authors: Brooke
authors: Patricia
authors: P
authors: Murray
authors: Sarah
authors: S
authors: Barlow
authors: Tony
authors: T
authors: Rossetti
authors: Rebecca
authors: R
authors: Pelekanos
authors: Sonia
authors: S
authors: Hancock
authors: Kerry
authors: K
authors: Atkinson
mesh_terms: D000818:Animals; D018929:Cell Culture Techniques; D002467:Cell Nucleus / Q000378:metabolism; D002469:Cell Separation; D015925:Cryopreservation; D005260:Female; D005434:Flow Cytometry; D006801:Humans; D008420:Manufactured Materials / Q000592:standards*; D059630:Mesenchymal Stem Cells / Q000166:cytology*; D039902:Multipotent Stem Cells / Q000166:cytology*; D010641:Phenotype; D010920:Placenta / Q000166:cytology*; D011247:Pregnancy; D011356:Product Labeling; D013242:Sterilization