December 7, 2011
‘Gold Standard’ Embryonic Stem Cell Lines Developed
Researchers from King's College London have produced the first animal product-free clinical grade human embryonic stem cell lines.
Scientists have submitted to the U.K. Stem Cell Bank (UKSCB) their first clinical grade human embryonic stem (hES) cell lines that are free from animal-derived products, or "xeno-free".They expect that these cells will be grown and processed by the UKSCB to provide stem cell stocks that will be used for clinical research and treatment to benefit patients.
"This is a significant achievement of the team, one which we have been working towards for many years with the support of the University, our local hospital, and most importantly the Medical Research Council," Professor Peter Braude, Emeritus Professor of Obstetrics and Gynaecology, King's College London, said in a press release.
The cells have the potential to become the "gold standard" lines for developing new stem cell-based therapies. Researchers say this is a significant milestone.
"We have succeeded where many substantial commercial companies have not," Braude said in a press release. "Many more xeno-free lines should follow, which demonstrates the validity and foresight of this and previous governments in this important endeavor."
Embryonic stem cells can be grown in the laboratory indefinitely while retaining their capacity to develop into specialized cell types like nerve or heart muscle cells.
Over 20 "research grade" stem cell lines have been provided by King's to the UKSCB since it derived the first research grade hES cell lines in the U.K. in 2003.
Clinical use of hES cells is already being explored in a number of phase 1 safety trials, such as spinal cord injury and macular degeneration. However, the hES cell lines used in these trials were reclassified from "research grade" to "clinical grade" for specified short-term clinical studies.
"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 researchers wrote.
The cells were grown from frozen embryos donated by patients who had undergone IVF treatment and no longer wished to use their remaining stored embryos.
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," the King's College press release read. "It is hoped that these standards will be recognized across academia, future users and policy agencies operating in and monitoring the field."
An early online paper on the methodology and standards developed by King´s College London for the derivation of xeno-free hES cells is available from Cytotherapy, the official journal of the International Society for Cellular Therapy.
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