A team from King’s College London said on Monday they were submitting two clinical-grade stem cell lines to the UK Stem Cell Bank (UKSBC), which will test and validate them before offering them to researchers.
Previous embryonic stem cell (ESC) trials in humans have used lower-quality “research grade” cells, which are manipulated and reclassified into “clinical grade”.
“This first batch of cells is the culmination of nearly 10 years of research. This is a significant milestone,” said Peter Braude, who led the King’s team.
The cells are the first to be grown completely free from animal-derived products, known as “xeno-free,” and developed specifically to be of clinical grade and for public use.
The cells have the potential to become the “gold standard” lines for developing new stem cell based therapies for use in regenerative medicine trials in patients, Braude told reporters at a briefing.
Prof Peter Braude, a leading member of the team, 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.”
He said: “Cells that are ready for clinical use have really been the Holy Grail of everybody in terms of regenerative medicine.
“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.”
Stem cells are the body’s master cells, the source for all other cells. Scientists say they could transform medicine, providing treatments for blindness, spinal cord and other severe injuries, as well as generating cells for damaged organs.
Human embryonic stem (hES) cells can be grown in the laboratory indefinitely while retaining their capacity to develop into specialized cell types, such as nerve or heart muscle cells, which can then be used in clinical trials.
A few companies, such as Pfizer and Advanced Cell Technology, are already conducting or are about to start human trials using hES cells — which are harvested from embryos — to test their potential for repairing spinal cord injuries and eye disorders like macular degeneration.
But the hES cell lines for these early trials were reclassified from “research grade” to “clinical grade” for specific short-term clinical studies in selected disease areas.
“In the future, patients hoping for the benefit of regenerative medicine for serious medical conditions caused by illness, injury and ageing can expect improved progress on cures or amelioration from hES cell-based therapy,” said Dusko Ilic, a senior lecturer in stem cell science at King’s.
It is widely believed that ESCs could one day be used to generate healthy tissue to replace damaged cells throughout the body, and potentially form the basis of new treatments for conditions like heart disease and Parkinson’s.
ESCs are taken from frozen embryos the size of a pinhead, which are donated to researchers by IVF patients who have no further use for them and would otherwise have been discarded. [via The Telegraph, Reuters and Daily Mail]