12:00 AM
Aug 25, 2011
 |  BC Innovations  |  Tools & Techniques

Taking out teratoma potential

Researchers at the Stanford University School of Medicine have developed an approach for separating human pluripotent stem cells from teratoma-forming cells in culture.1 The group thinks the procedure could help allay tumorigenicity concerns associated with stem cell-derived therapies and plans to use the approach to test existing therapeutic-grade stem cell-derived pancreatic cells and neural progenitors for their teratoma-forming potential.

When researchers differentiate pluripotent of stem cells, a trace number may remain in an undifferentiated state. These undifferentiated cells can form teratomas in animals.2 Teratomas are tumors that contain cells derived from all three germ tissue layers.

Indeed, the potential for tumorigenicity has prompted the FDA to require developers of stem cell-derived therapies to run assays and animal studies showing no residual undifferentiated cells and no tumor formation.

Companies have attempted to address the tumorigenicity concerns by developing assays and by tweaking their manufacturing processes, such as using a protracted differentiation protocol to increase the homogeneity of the clinical product.

Assays detect but do not remove the undifferentiated cells, and changes to the manufacturing process do not guarantee the absence of undifferentiated cells in the clinical product.

"There is currently no gold standard for removing teratoma-forming cells from differentiated cultures," said Chad Tang, a medical student at Stanford and lead author on the Nature Biotechnology paper.

"We wanted to develop a prospective method to remove the teratoma risk of undifferentiated cells," added Micha Drukker, co-corresponding author on the paper anda postdoctoral scholar...

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