Stem cells hold a great promise for regenerative medicine given their ability
to proliferate and differentiate into various cell types. However, self-renewal and
multipotency also grant a high capacity to form tumor tissues in vivo post-therapeutic
administration. Indeed, multiple case reports have revealed the formation of stem cell derived tumors, such as teratoma, in animal models and even in clinical applications.
As a result, examination of tumorigenicity becomes one of the major considerations
when assessing the safety of stem cell-derived therapeutic products. Ideally, the
assessment needs to be performed in a rapid, sensitive, cost-effective, and scalable
manner. In this chapter, the current practices of assay development to fulfill this
demand are reviewed. Progress in animal models, soft agar culture, PCR, flow
cytometry, and microfluidics are introduced and compared comprehensively. Some
insights regarding the assay selection and future development are also provided as there
is no one-for-all assay at this moment.
Keywords: Assay development, Biomanufacturing, Cell therapy, Cancer initiation, Quality assurance, Stem cells, Tumorigenicity.
