Expansion of Mesenchymal Stem/Stromal Cells under Xenogenic-Free Culture Conditions
Mesenchymal Stem/Stromal cells (MSCs) are increasingly applied in cell-based regenerative medicine. To yield clinically relevant cell doses, ex vivo expansion of MSCs is required to be compliant with good manufacturing practice (GMP) guidelines. A lack of
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Expansion of Mesenchymal Stem/Stromal Cells under Xenogenic-Free Culture Conditions Sven Kinzebach and Karen Bieback Abstract Mesenchymal Stem/Stromal cells (MSCs) are increasingly applied in cell-based regenerative medicine. To yield clinically relevant cell doses, ex vivo expansion of MSCs is required to be compliant with good manufacturing practice (GMP) guidelines. A lack of standardization and harmonization seems to hamper rapid progress in the translational phase. Most protocols still use fetal bovine serum (FBS) to expand MSCs. However, the high lot-to-lot variability, risk of contamination and immunization call for xenogenic-free culture conditions. Chemically defined media are the ultimate achievement in terms of standardization. These media, however, need to maintain all key cellular and therapy-relevant features of MSCs. Because of the numerous constituents of FBS, the development of such chemically defined media with an optimal composition of the few essential factors is only beginning. Meanwhile, various human blood-derived components are under investigation, including human plasma, human serum, human umbilical cord blood serum and human platelet derivatives such as platelet lysate.
Keywords Chemically defined medium Fetal bovine serum Human serum Mesenchymal stem cells Mesenchymal stromal cells Platelet lysate Serum-free medium Standardization Xenogenic-free medium
S. Kinzebach K. Bieback (&) Institute of Transfusion Medicine and Immunology, Medical Faculty Mannheim, Heidelberg University, German Red Cross Blood Service Baden-Württemberg–Hessen, Friedrich-Ebert-Str. 107, 68167 Mannheim, Germany e-mail: [email protected] S. Kinzebach e-mail: [email protected]
S. Kinzebach and K. Bieback
Contents 1 2
Mesenchymal Stem/Stromal Cells .......................................................................................... Clinical Application: Balancing Success and Risks .............................................................. 2.1 Success ............................................................................................................................ 2.2 Risks................................................................................................................................ 2.3 Regulatory Frameworks.................................................................................................. 3 MSC Manufacturing ................................................................................................................ 4 Towards Xenogenic-Free Culture Conditions for MSC Expansion ...................................... 4.1 Fetal Bovine Serum ........................................................................................................ 4.2 Serum-Free Cell Culture Media..................................................................................... 4.3 Xenogenic-Free Media ................................................................................................... 5 Pathogen Reduc
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