Development of an In Vitro Teratoma Assay


To optimize an in vitro assay for screening stem cells and stem cell-derived therapies for tumor-forming potential

Anticipated Impact: 

Safer stem cell-based therapies and reduced animal use during therapeutic development


Stem cells are a promising approach for treating many serious diseases, as they have the capacity to differentiate into multiple cell types (a characteristic known as pluripotency). In developing stem cell-derived products for clinical use, it is critical to verify the pluripotency of the stem cells used to generate the products, as well as assess whether those products have the potential to form tumors (a major concern for stem cell-based therapy). The current gold standard for such testing is the teratoma assay, in which cells are injected into mice and assessed for their ability to form tumors (teratomas). This in vivo assay has significant drawbacks: it requires large numbers of animals, is prohibitively expensive and labor-intensive, and often yields variable results due to non-standardized protocols. Dr. Cirulli and his team at University of Washington are collaborating with a local biotechnology company, Nortis, to develop a cost-effective teratoma assay that can be performed at the lab bench with good reproducibility. This grant will support additional validation of this in vitro assay to better position the product for commercialization.

Collaborating organization: Nortis

Stem Cell Therapies

Grant Update

Principal Investigator:
Vincenzo Cirulli
Grantee Organization:
University of Washington
Grant Title:
Development of an in vitro Teratoma assay
Grant Cohort and Year:
2014 Proof of Concept (03)
Grant Period:
02/16/2014 - 02/15/2016 (Completed)
Grant Amount:
Support under this award enabled us to develop a novel technology that will permit the assessment of stem cells’ pluripotency in vitro. The significance of this new method, based on microfluidic technologies developed by Nortis, is that the assessment of stem cell pluripotency can be tested without the need of prohibitively expensive in vivo animal testing for teratoma development.

Impact in Washington

Location of LSDF Grantee
Locations of Collaborations/Areas of Impact

Legislative Districts:
11, 34, 36, 37, 43, 46

Health Impacts

Stem Cell Therapies