I’d like to shave very recent review about the current status of clinical-scale manufacturing of mesenchymal stromal cells (MSC):
This paper will focus on the definition of mesenchymal stromal cells (MSCs), and challenges and achievements in the manufacturing process enabling their use in clinical studies. It will allude to different cellular sources, special capacities of MSCs, but also to current regulations, with a special focus on accessory material of human or animal origin, like media supplements.
More excerpts that I like:
Controversies about characteristics and potencies exist most probably due to the fact that different laboratories employ not only different tissue sources, but also extraction methods, culture protocols, and characterisation tools. Any variation may result in isolation and expansion of different subpopulations of cells or may change characteristics of the cells.
Given the fact that even MSCs used in clinical trials are produced and characterised by a variety of different protocols, reproduction or interpretation of the clinical results may be hampered . Accordingly, standardized protocols have to be developed assuring that the manufactured cells behave solely in the clinically intended purpose and do not exert adverse effects by, for example, uncontrolled differentiation or transformation.
Therefore, an essential requirement is that all steps in MSC manufacturing from starting material up to potency testing for the intended indication have to be highly standardized to assure a required and reproducible cellular quality and potency. The challenge for scientists aiming at producing MSCs for clinical trials is to define optimal cell culture conditions to efficiently isolate and ex vivo expand homogenous MSCs while maintaining cellular qualities required for the intended clinical application and minimising risks of adverse events.
Very good review recommended to read!