r of expediency. This route is not considered appropriate for the future of cell therapy because of the expense of the required testing and reclassification, and the significant risk of using cell lines derived on unqualified feeders, using unqualified reagents under undocumented environmental conditions in the embryology and stem cell labs and storage facilities. While it might be reasonable to incur additional risks for these early pioneering studies, it is not reasonable to accept these risks for the long-term future of cell therapy. Therefore the highest standard of xeno-free lines are urgently needed, and the development of these lines by King's represents a major step forward.
The hES cells were grown from frozen embryos donated by patients who had previously undergone IVF treatment and no longer wished to use their remaining stored embryos. These embryos would otherwise have been discarded in line with HFEA requirements.
The work took place in the purpose-built stem cell laboratory at King's, in collaboration with the Assisted Conception Unit at Guy's and St Thomas' NHS Foundation Trust, as part of King's Health Partners Academic Health Sciences Centre, and licensed by the Human Fertilisation and Embryology Authority (HFEA) and the Human Tissue Authority (HTA). The laboratory is compliant with Current Good Manufacturing Practices (cGMP).
The team developed a comprehensive methodology and standards for derivation of the xeno-free hES cell lines that will be appropriate for studies in human subjects after suitable additional testing and processing by the UKSCB. Developed in line with these rigorous standards, researchers, physicians and industry can be reassured of the reliability of the seed stock the essential base for translational applications. It is hoped that these standards will be recognised across academia, future users and policy agencies operating in and monitoring the field.
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