“Gold standard” stem cells for clinical testing

By Dr. Ananya Mandal, MDDec 7 2011

British researchers claim to have created stem cells of a “gold standard” quality that could lead to a new wave of treatments for degenerative diseases. Taken from human embryos, they could be available to researchers before the end of next year for eventual use in clinical trials, The Daily Telegraph reported Tuesday.

Earlier embryonic stem cell trials in humans have been conducted with lower-quality "research grade" cells which are manipulated and reclassified as “clinical grade,” but the new cells are of clinical quality from the moment they are donated and do not require a costly and risky conversion, researchers said. Researchers from King's College London have donated the cells to the UK Stem Cell Bank, where they will undergo testing to ensure they are safe and of a quality suitable for use in human trials.

“Cells that are ready for clinical use have really been the Holy Grail of everybody in terms of regenerative medicine,” Peter Braude, a leading member of the Kings College team, said. They are also untainted by animal-derived products which have been used by other researchers to stimulate growth. Two lines of stem cells that can be converted into virtually any type of tissue in the body have been donated. Braude said, “The key here is that these are clinical grade lines, they have been set up from the beginning as lines that do not contain animal products and have not got animal products coming into contact with them.” Prof Braude said the achievement, recorded in the Cytotherapy journal, marked ten years of painstaking research.

The researchers explained that the cells are taken from pinhead-sized embryos donated to researchers by in vitro fertilization patients who have no further use for them, and the embryos would otherwise have been discarded, The Daily Telegraph reported. Dr Glyn Stacey, director of the UKSCB, said, “They will be released – I wouldn't like to put a date on it, but sometime next year. The moment we release them they are ready for use in a clinical trial.”

While ESCs (Embryonic stem cells) of similar quality could potentially have been cultured in secret by private researchers such as drug companies, these are the first of their kind to be developed for public health benefit. A line of cells of a similar quality is being developed by Manchester University researchers and is expected to be donated to the stem cell bank next month.

“There is still a long way to go ... these are not ready for use now. They get handed over to the stem cell bank and they do exhaustive testing and a lot of lines are going to fail,” Braude said.