Methods for detection and elimination of residual human embryonic stem cells in a differentiated cell product

The Early Translational Awards, which are funded annually, either lead to a drug candidate for an unmet medical need or address a bottleneck in the development of new therapies. The 16 Early Translational I awards worth $71,570,007 were awarded on 4/29/09. You can learn more about the awards by reading the RFA or reading the press release.

Public Abstract (provided by applicant)

Human embryonic stem cells (hESC), and other related pluripotent stem cells, have great potential as starting material for the manufacture of curative cell therapies. This is primarily for two reasons. First, by manipulating cues in their cell culture conditions, these cells can be directed to become essentially any desired human cell type (a property known as pluripotency). Second, hESC have the remarkable capacity to expand rapidly with essentially no change in their identity. At a practical level, this means enough cells to manufacture thousands, and even millions, of therapeutic cell doses can be generated in a matter of weeks. Thus, the biomedical potential is tremendous, but several practical matters remain to be resolved. One of the biggest concerns is that manufacturing processes, i.e., methods to direct

Statement of benefit to California (provided by applicant)

In large part through CIRM initiatives, California hopes to further establish itself as the world center for stem cell research and stem cell-derived therapies. One major issue standing in the way of stem cell-derived therapy development is the possibility of a teratoma forming after transplant with a stem cell-derived cell therapy. A teratoma is a disorganized tissue amalgam containing various different cell types, and is generally a benign tumor. Teratomas can form in animals transplanted with stem cells, and therefore if some stem cells persist in the stem-cell derived therapy, there exists a possibility that teratomas will form in a patient