Protocol

Mesenchymal Stem Cell Assays and Applications

Volume 698 of the series Methods in Molecular Biology pp 89-106

Date:

Manufacture of Clinical Grade Human Placenta-Derived Multipotent Mesenchymal Stromal Cells

  • Nina Ilic
  • , Gary Brooke
  • , Patricia Murray
  • , Sarah Barlow
  • , Tony Rossetti
  • , Rebecca Pelekanos
  • , Sonia Hancock
  • , Kerry AtkinsonAffiliated withMater Health ServicesMater Medical Research InstituteUniversity of Queensland Email author 

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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.

Key words

Mesenchymal stem cells/multipotent progenitor cells Placenta Isolation Expansion Tissue culture cGMP Clinical grade Quality assurance