Tumorigenicity studies for human pluripotent stem cell-derived products

Takuya Kuroda, Satoshi Yasuda, Yoji Sato

Research output: Contribution to journalArticlepeer-review

35 Citations (Scopus)


Human pluripotent stem cells (hPSCs), i.e. human embryonic stem cells and human induced pluripotent stem cells, are able to self-renew and differentiate into multiple cell types. Because of these abilities, numerous attempts have been made to utilize hPSCs in regenerative medicine/cell therapy. hPSCs are, however, also tumorigenic, That IS, they can give rise to the progressive growth of tumor nodules in immunologically unresponsive animals. Therefore, assessing and managing the tumorigenicity of all final products is essential in order to prevent ectopic tissue formation, tumor development, and/or malignant transformation elicited by residual pluripotent stem cells after implantation. No detailed guideline for the tumorigenicity testing of hPSC-derived products has yet been issued for regenerative medicine/cell therapy, despite the urgent necessity. Here, we describe the current situations and issues related to the tumorigenicity testing of hPSC-derived products and we review the advantages and disadvantages of several types of tumorigenicity-associated tests. We also refer to important considerations in the execution and design of specific studies to monitor the tumorigenicity of hPSC-derived products.

Original languageEnglish
Pages (from-to)189-192
Number of pages4
JournalBiological and Pharmaceutical Bulletin
Issue number2
Publication statusPublished - 2013 Feb
Externally publishedYes


  • Cell therapy
  • Embryonic stem cell
  • Induced pluripotent stem cell
  • Pluripotent stem cell
  • Regenerative medicine
  • Tumorigenicity

ASJC Scopus subject areas

  • Pharmacology
  • Pharmaceutical Science


Dive into the research topics of 'Tumorigenicity studies for human pluripotent stem cell-derived products'. Together they form a unique fingerprint.

Cite this