Manufacturing perinatal stem cells for clinical applications

Abstract

Mesenchymal cells are being increasingly explored in clinical trials. They are promising candidates for allogeneic off-the-shelf cellular therapy because they preferentially migrate to sites of inflammation and injury and can be transplanted into patients without the need for immune suppression. We used mesenchymal stromal cells derived from term placenta for our clinical trial program exploring the use of these cells. In this chapter we describe the methods that we utilised to harvest and administer these cells according to the Code of Good Manufacturing Practice principles and according to policies and procedures of our internal Quality Management System based on the International Organisation for Standardisation (ISO) requirements. Although hematopoietic stem cells are present in placenta, this chapter focuses solely on mesenchymal cells in the term placenta.