There are problems with scalability of embryonic stem cells, as well as the fact that animal derived products are conventionally used during their culture. While fetal calf serum has previously been used, and is continued to be used in a lot of the stem cell clinical trials going on, there is always a desire to have "animal free" cells for clinical development. Companies such as Novocell have IP on neat ways of using human feeder cells instead of mouse feeder cells for embryonic stem cell expansion. Geron has some IP on not using feeder cells at all, but instead using extracellular matrix extracts.
The current patent has some very broad language in the issued claims. Lets look at claim 1:
A method of culturing human embryonic stem cells, comprising: culturing human embryonic stem cells on a matrix in a culture medium free of serum and in a stem cell culture medium containing amino acids, vitamins, salts, minerals, transferrin or a transferrin substitute, insulin or an insulin substitute, albumin, and a fibroblast growth factor supplied from a source other than a feeder layer, the fibroblast growth factor present in a concentration at least as high as a maintenance concentration, wherein the medium supports the culture and proliferation of undifferentiated proliferating euploid human embryonic stem cells for at least six passages without feeder cells or conditioned medium.
So we can see that it pretty much covers any media as long as there is: a) a matrix; b) no serum; c) amino acids, vitamins, salts, minerals, d) transferrin or a transferrin substitute; e) insulin or an insulin substitute; f) albumin; g) a fibroblast growth factor from a source other than a feeder layer, and the FGF to be at a concentration enough to "maintain" the ES cells; and h) the medium supports the culture and proliferation of the chromosomally normal ES cells for at least 6 passages.
Conceptually, such a claim could cover many many things. Of course types of FGF and concentrations are provided in the dependent claims.
View this patent on the USPTO website.
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