Sotiropoulou Panagiota A, Perez Sonia A, Salagianni Maria, Baxevanis Constantin N, Papamichail Michael
Stem Cells. 2006 May;24(5):1409-10. doi: 10.1634/stemcells.2005-0654. Epub 2006 Jan 26.
The use of fetal calf serum (FCS) for the culture of cells to be used in clinical trials raises potential hazards that cannot be neglected, but this is a regulatory issue. However, as specifically regards the isolation and expansion of human mesenchymal stem cells (MSCs), unfortunately serum-free media have not yet been defined. The alternative of using autologous serum is feasible only for the minority of clinical protocols involving low numbers of MSCs, because a minimum concentration of 10% in the culture medium is required. Besides, because allogeneic serum results in MSC growth arrest and death, use of pooled human serum does not represent an alternative. Finally, vast numbers of MSCs cultured in FCS-containing media have already been used in many clinical trials targeting a variety of disorders, without any significant side effects, including ventricular arrhythmia.
在临床试验中使用胎牛血清（FCS）培养细胞会带来不可忽视的潜在危害，但这是一个监管问题。然而，具体就人间充质干细胞（MSC）的分离和扩增而言，遗憾的是，无血清培养基尚未确定。使用自体血清的替代方法仅对少数涉及少量MSC的临床方案可行，因为培养基中需要至少10%的浓度。此外，由于异体血清会导致MSC生长停滞和死亡，使用混合人血清并非一种替代方法。最后，大量在含FCS培养基中培养的MSC已被用于许多针对各种疾病的临床试验中，且未出现任何显著副作用，包括室性心律失常。
