Teratoma formation by human embryonic stem cells: Evaluation of essential parameters for future safety studies

Stem Cell Research - Tập 2 - Trang 198-210 - 2009
Hannes Hentze1, Poh Loong Soong1, Siew Tein Wang1, Blaine W. Phillips1, Thomas C. Putti2, N. Ray Dunn1
1ES Cell International Pte Ltd, 60 Biopolis Street, No. 01-03 Genome, Singapore, 138672 Singapore
2Department of Pathology, National University Health System, 5 Lower Kent Ridge Road, 119074 Singapore

Tài liệu tham khảo

Adewumi, 2007, Characterization of human embryonic stem cell lines by the International Stem Cell Initiative, Nat. Biotechnol., 25, 803, 10.1038/nbt1318 Amit, 2003, Human feeder layers for human embryonic stem cells, Biol. Reprod., 68, 2150, 10.1095/biolreprod.102.012583 Blum, 2007, Clonal analysis of human embryonic stem cell differentiation into teratomas, Stem Cells, 258, 1924, 10.1634/stemcells.2007-0073 Blum, 2008, The tumorigenicity of human embryonic stem cells, Adv. Cancer Res., 100, 133, 10.1016/S0065-230X(08)00005-5 Bongso, 1994, Human embryonic behavior in a sequential human oviduct-endometrial coculture system, Fertil. Steril., 61, 976, 10.1016/S0015-0282(16)56717-X Brederlau, 2006, Transplantation of human embryonic stem cell-derived cells to a rat model of Parkinson's disease: effect of in vitro differentiation on graft survival and teratoma formation, Stem Cells, 24, 1433, 10.1634/stemcells.2005-0393 Brivanlou, 2003, Setting standards for human embryonic stem cells, Science, 300, 913, 10.1126/science.1082940 Cai, 2007, Transplantation of embryonic stem cell-derived cardiomyocytes improves cardiac function in infarcted rat hearts, Cytotherapy, 9, 283, 10.1080/14653240701247838 Choo, 2004, Expansion of pluripotent human embryonic stem cells on human feeders, Biotechnol. Bioeng., 88, 321, 10.1002/bit.20247 Choo, 2008, Selection against undifferentiated human embryonic stem cells by a cytotoxic antibody recognizing podocalyxin-like protein-1, Stem Cells, 26, 1454, 10.1634/stemcells.2007-0576 Cooke, 2006, Growth of teratomas derived from human pluripotent stem cells is influenced by the graft site, Stem Cells Dev., 15, 254, 10.1089/scd.2006.15.254 Costa, 2005, The hESC line Envy expresses high levels of GFP in all differentiated progeny, Nat. Methods, 2, 259, 10.1038/nmeth748 Crook, 2007, The generation of six clinical-grade human embryonic stem cell lines, Cell Stem Cell, 1, 490, 10.1016/j.stem.2007.10.004 Damjanov, 2007, The terminology of teratocarcinomas and teratomas, Nat. Biotechnol., 25, 1212, 10.1038/nbt1107-1212a De Coppi, 2007, Isolation of amniotic stem cell lines with potential for therapy, Nat. Biotechnol., 25, 100, 10.1038/nbt1274 Dressel, 2008, The tumorigenicity of mouse embryonic stem cells and in vitro differentiated neuronal cells is controlled by the recipients' immune response, PLoS ONE, 3, e2622, 10.1371/journal.pone.0002622 Drukker, 2006, Human embryonic stem cells and their differentiated derivatives are less susceptible to immune rejection than adult cells, Stem Cells, 24, 221, 10.1634/stemcells.2005-0188 Eshpeter, 2008, In vivo characterization of transplanted human embryonic stem cell-derived pancreatic endocrine islet cells, Cell Prolif., 41, 843, 10.1111/j.1365-2184.2008.00564.x Ellerstrom, 2007, Facilitated expansion of human embryonic stem cells by single cell enzymatic dissociation, Stem Cells, 25, 1690, 10.1634/stemcells.2006-0607 FDA, 2006. Supplemental guidance on testing for replication competent retrovirus in retroviral vector based gene therapy products and during follow-up of patients in clinical trials using retroviral vectors. http://www.fda.gov/CBER/gdlns/retrogt1000.pdf. FDA, 2008a. Cellular therapies derived from human embryonic stem cells—considerations for pre-clinical safety testing and patient monitoring. http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-0471B1_1.pdf. FDA, 2008b. Cellular therapies derived from human embryonic stem cells scientific http://wwwfdagov/ohrms/dockets/ac/cber08html#CellularTissueGeneTherapies. Fujikawa, 2005, Teratoma formation leads to failure of treatment for type I diabetes using embryonic stem cell-derived insulin-producing cells, Am. J. Pathol., 166, 1781, 10.1016/S0002-9440(10)62488-1 Gertow, 2007, Trisomy 12 in HESC leads to no selective in vivo growth advantage in teratomas, but induces an increased abundance of renal development, J. Cell. Biochem., 100, 1518, 10.1002/jcb.21144 Gertow, 2004, Organized development from human embryonic stem cells after injection into immunodeficient mice, Stem Cells Dev., 13, 421, 10.1089/scd.2004.13.421 Graichen, 2007, Enhanced cardiomyogenesis of human embryonic stem cells by a small molecular inhibitor of p38 MAPK, Differentiation, 76, 357, 10.1111/j.1432-0436.2007.00236.x Guo, 2006, Creation of engineered cardiac tissue in vitro from mouse embryonic stem cells, Circulation, 113, 2229, 10.1161/CIRCULATIONAHA.105.583039 Halme, 2006, FDA regulation of stem-cell-based therapies, N. Engl. J. Med., 355, 1730, 10.1056/NEJMhpr063086 Hasegawa, 2006, A method for the selection of human embryonic stem cell sublines with high replating efficiency after single-cell dissociation, Stem Cells, 24, 2649, 10.1634/stemcells.2005-0657 Hentze, 2007, Cell therapy and the safety of embryonic stem cell-derived grafts, Trends Biotechnol., 25, 24, 10.1016/j.tibtech.2006.10.010 Keller, 2005, Embryonic stem cell differentiation: emergence of a new era in biology and medicine, Genes Dev., 19, 1129, 10.1101/gad.1303605 Kelly, 2007, Tumor growth need not be driven by rare cancer stem cells, Science, 317, 337, 10.1126/science.1142596 Kroon, 2008, Pancreatic endoderm derived from human embryonic stem cells generates glucose-responsive insulin-secreting cells in vivo, Nat. Biotechnol., 26, 443, 10.1038/nbt1393 Kumashiro, 2005, Enrichment of hepatocytes differentiated from mouse embryonic stem cells as a transplantable source, Transplantation, 79, 550, 10.1097/01.TP.0000153637.44069.C6 Laflamme, 2005, Formation of human myocardium in the rat heart from human embryonic stem cells, Am. J. Pathol., 167, 663, 10.1016/S0002-9440(10)62041-X Lawrenz, 2004, Highly sensitive biosafety model for stem-cell-derived grafts, Cytotherapy, 6, 212, 10.1080/14653240410006031 Leist, 2008, The biological and ethical basis of the use of human embryonic stem cells for in vitro test systems or cell therapy, ALTEX, 25, 163, 10.14573/altex.2008.3.163 Lensch, 2007, The terminology of teratocarcinomas and teratomas, Nat. Biotechnol., 25, 1211, 10.1038/nbt1107-1211a Nagy, 2003 Phillips, 2007, Directed differentiation of human embryonic stem cells into the pancreatic endocrine lineage, Stem Cells Dev., 16, 561, 10.1089/scd.2007.0029 Phillips, 2008, Efficient expansion of clinical-grade human fibroblasts on microcarriers: cells suitable for ex vivo expansion of clinical-grade hESCs, J. Biotechnol., 134, 79, 10.1016/j.jbiotec.2007.12.007 Phillips, 2008, Attachment and growth of human embryonic stem cells on microcarriers, J. Biotechnol., 138, 24, 10.1016/j.jbiotec.2008.07.1997 Plaia, 2006, Characterization of a new NIH-registered variant human embryonic stem cell line, BG01V: a tool for human embryonic stem cell research, Stem Cells, 24, 531, 10.1634/stemcells.2005-0315 Prokhorova, T.A., Harkness, L.M., Frandsen, U., Ditzel, N., Burns, J.S., Schroeder, H.D., Kassem, M., 2008. Teratoma formation by human embryonic stem cells is site-dependent and enhanced by the presence of matrigel. Stem Cells Dev., in press (doi:10.1089/scd.2007.0266). Przyborski, 2005, Differentiation of human embryonic stem cells after transplantation in immune-deficient mice, Stem Cells, 23, 1242, 10.1634/stemcells.2005-0014 Quintana, 2008, Efficient tumour formation by single human melanoma cells, Nature, 456, 593, 10.1038/nature07567 Reubinoff, 2001, Neural progenitors from human embryonic stem cells, Nat. Biotechnol., 19, 1134, 10.1038/nbt1201-1134 Reubinoff, 2000, Embryonic stem cell lines from human blastocysts: somatic differentiation in vitro, Nat. Biotechnol., 18, 399, 10.1038/74447 Shibata, 2006, Improved safety of hematopoietic transplantation with monkey embryonic stem cells in the allogeneic setting, Stem Cells, 24, 1450, 10.1634/stemcells.2005-0391 Solter, 2006, From teratocarcinomas to embryonic stem cells and beyond: a history of embryonic stem cell research, Nat. Rev. Genet., 7, 319, 10.1038/nrg1827 Stojkovic, 2005, An autogeneic feeder cell system that efficiently supports growth of undifferentiated human embryonic stem cells, Stem Cells, 23, 306, 10.1634/stemcells.2004-0137 Takahashi, 2007, Induction of pluripotent stem cells from adult human fibroblasts by defined factors, Cell, 131, 861, 10.1016/j.cell.2007.11.019 Thomson, 1998, Embryonic stem cell lines derived from human blastocysts, Science, 282, 1145, 10.1126/science.282.5391.1145 Tian, 2006, Hematopoietic engraftment of human embryonic stem cell-derived cells is regulated by recipient innate immunity, Stem Cells, 24, 1370, 10.1634/stemcells.2005-0340 Tomescot, 2007, Differentiation in vivo of cardiac committed human embryonic stem cells in post-myocardial infarcted rats, Stem Cells, 25, 2200, 10.1634/stemcells.2007-0133 Tzukerman, 2006, The influence of a human embryonic stem cell-derived microenvironment on targeting of human solid tumor xenografts, Cancer Res., 66, 3792, 10.1158/0008-5472.CAN-05-3467 Vogel, 2005, Ready or not? Human ES cells head toward the clinic, Science, 308, 1534, 10.1126/science.308.5728.1534 Xu, 2008, Highly enriched cardiomyocytes from human embryonic stem cells, Cytotherapy, 10, 376, 10.1080/14653240802105307 Yu, 2007, Induced pluripotent stem cell lines derived from human somatic cells, Science, 318, 1917, 10.1126/science.1151526 Zhang, 2001, In vitro differentiation of transplantable neural precursors from human embryonic stem cells, Nat. Biotechnol., 19, 1129, 10.1038/nbt1201-1129