Next Article in Journal
NLRP3 Inflammasome and Pathobiology in AMD
Next Article in Special Issue
The State of Play with iPSCs and Spinal Cord Injury Models
Previous Article in Journal
Three Adult Cases of Orbital Hidrocystoma Presenting with Blepharoptosis
Previous Article in Special Issue
Scalable Electrophysiological Investigation of iPS Cell-Derived Cardiomyocytes Obtained by a Lentiviral Purification Strategy
Open AccessReview

Design of a Tumorigenicity Test for Induced Pluripotent Stem Cell (iPSC)-Derived Cell Products

Research and Development Center for Cell Therapy, Foundation for Biomedical Research and Innovation, TRI#308 1-5-4, Minatojima-Minamimachi, Chuo-ku, Kobe 650-0047, Japan
Laboratory for Retinal Regeneration, RIKEN Center for Developmental Biology, 2-2-3, Minatojima-Minamimachi, Chuo-ku, Kobe 650-0047, Japan
Author to whom correspondence should be addressed.
Academic Editor: Michael J. Edel
J. Clin. Med. 2015, 4(1), 159-171;
Received: 22 October 2014 / Accepted: 22 December 2014 / Published: 14 January 2015
(This article belongs to the Special Issue iPS Cells for Modelling and Treatment of Human Diseases)
Human Pluripotent Stem Cell (PSC)-derived cell therapy holds enormous promise because of the cells’ “unlimited” proliferative capacity and the potential to differentiate into any type of cell. However, these features of PSC-derived cell products are associated with concerns regarding the generation of iatrogenic teratomas or tumors from residual immature or non-terminally differentiated cells in the final cell product. This concern has become a major hurdle to the introduction of this therapy into the clinic. Tumorigenicity testing is therefore a key preclinical safety test in PSC-derived cell therapy. Tumorigenicity testing becomes particularly important when autologous human induced Pluripotent Stem Cell (iPSC)-derived cell products with no immuno-barrier are considered for transplantation. There has been, however, no internationally recognized guideline for tumorigenicity testing of PSC-derived cell products for cell therapy. In this review, we outline the points to be considered in the design and execution of tumorigenicity tests, referring to the tests and laboratory work that we have conducted for an iPSC-derived retinal pigment epithelium (RPE) cell product prior to its clinical use. View Full-Text
Keywords: PSC-derived cell therapy; iPSC; RPE; tumorigenicity test PSC-derived cell therapy; iPSC; RPE; tumorigenicity test
Show Figures

Figure 1

MDPI and ACS Style

Kawamata, S.; Kanemura, H.; Sakai, N.; Takahashi, M.; Go, M.J. Design of a Tumorigenicity Test for Induced Pluripotent Stem Cell (iPSC)-Derived Cell Products. J. Clin. Med. 2015, 4, 159-171.

Show more citation formats Show less citations formats

Article Access Map by Country/Region

Only visits after 24 November 2015 are recorded.
Back to TopTop