Highly sensitive biosafety model for stem-cell-derived grafts

Assady, 2001, Insulin production by human embryonic stem cells, Diabetes, 50, 1691, 10.2337/diabetes.50.8.1691 Hori, 2002, Growth inhibitors promote differentiation of insulin-producing tissue from embryonic stem cells, Proc Natl Acad Sci USA, 99, 16105, 10.1073/pnas.252618999 Kehat, 2001, Human embryonic stem cells can differentiate into myocytes with structural and functional properties of cardiomyocytes, J Clin Invest, 108, 407, 10.1172/JCI200112131 Reubinoff, 2001, Neural progenitors from human embryonic stem cells, Nat Biotechnol, 19, 1134, 10.1038/nbt1201-1134 Zhang, 2001, In vitro differentiation of transplantable neural precursors from human embryonic stem cells, Nat Biotechnol, 19, 1129, 10.1038/nbt1201-1129 Bjorklund, 2002, Embryonic stem cells develop into functional dopaminergic neurons after transplantation in a Parkinson rat model, Proc Natl Acad Sci USA, 99, 2344, 10.1073/pnas.022438099 Zheng, 2002, Transplantation of an indigenous neural stem cell population leading to hyperplasia and atypical integration, Cloning Stem Cells, 4, 3, 10.1089/153623002753631995 Freed, 2001, Transplantation of embryonic dopamine neurons for severe Parkinson's disease, N Engl J Med, 344, 710, 10.1056/NEJM200103083441002 Bonini, 1997, HSV-TK gene transfer into donor lymphocytes for control of allogeneic graft-versus- leukemia, Science, 276, 1719, 10.1126/science.276.5319.1719 Muller, 2000, Selection of ventricular-like cardiomyocytes from ES cells in vitro, FASEB J, 14, 2540, 10.1096/fj.00-0002com Klug, 1996, Genetically selected cardiomyocytes from differentiating embryonic stem cells form stable intracardiac grafts, J Clin Invest, 98, 216, 10.1172/JCI118769 Schuldiner, 2003, Selective abla tion of human embryonic stem cells expressing a ‘Suicide’ gene, Stem Cells, 21, 257, 10.1634/stemcells.21-3-257 Fareed, 2002, Suicide gene transduction sensitizes murine embryonic and human mesenchymal stem cells to ablation on demand- a fail-safe protection against cellular misbehavior, Gene Ther, 9, 955, 10.1038/sj.gt.3301771 Gray, 2000, Conditionally immorta lized, multipotential and multifunctional neural stem cell lines as an approach to clinical transplantation, Cell Transplant, 9, 153, 10.1177/096368970000900203 Dufayet de la Tour, 2001, Beta-cell differentiation from a human pancreatic cell line in vitro and in vivo, Mol Endocrinol, 15, 476 The European Agency for the Evaluation of Medicinal Products (EMEA), Committee for proprietary medicinal products (CPMP): Note for guidance on the quality, preclinical and clinical aspects of gene transfer medicinal products, vol. CPMP/BWP/3088/99, 2001. EMEA. www.emea.eu.int/pdfs/human/bwp/308899en.pdf. The European Agency for the Evaluation of Medicinal products (EMEA), Committee for proprietary medicinal products (CPMP): Points to consider on the manufacture and quality control of human somatic cell therapy medicinal products, vol. CPMP/BWP/41450/98, 2001. EMEA. www.emea.eu.int/pdfs/human/bwp/4145098en.pdf. Li, 1992, Targeted mutation of the DNA methyltransferase gene results in embryonic lethality, Cell, 69, 915, 10.1016/0092-8674(92)90611-F Giard, 1973, In vitro cultivation of human tumors: establishment of cell lines derived from a series of solid tumors, J Natl Cancer Instit, 51, 1417, 10.1093/jnci/51.5.1417 Nicklas, 2000, Survey of embryonic stem cells for murine infective agents, Comp Med, 50, 410 Bahnemann, 1995, RITA-Registry of Industrial Toxicology Animal-data- guides for organ sam pling and trimming procedures in rats, Exp Toxicol Pathol, 47, 247, 10.1016/S0940-2993(11)80259-9 Romeis, 1989 Liu, 1997, Trisomy eight in ES cells is a common potential problem in gene targeting and interferes with germ line transmission, Dev Dyn, 209, 85, 10.1002/(SICI)1097-0177(199705)209:1<85::AID-AJA8>3.0.CO;2-T 1998 van Weerden, 1996, Frequent occurrence of spontaneous tumors in NMRI athymic nude mice, 41 Sharkey, 1984, Considerations in the use of nude mice for cancer research, Cancer Metastasis Rev, 3, 341, 10.1007/BF00051459 Sharkey, 1979, Incidence and pathological features of spontaneous tumors in athymic nude mice, Cancer Res, 39, 833 Gershwin, 1983, Anti-mu induces lymphoma in germfree congenitally athymic (nude) but not in heterozygous (nu/+) mice, J Immunol, 131, 2069, 10.4049/jimmunol.131.4.2069 Mohr, 2001 Hogan, 1994 Takahashi, 2003, Role of ERas in promoting tumour-like properties in mouse embryonic stem cells, Nature, 423, 541, 10.1038/nature01646 Pleasure, 1992, Pure, postmitotic, polarized human neurons derived from NTera 2 cells provide a system for expressing exogenous proteins in terminally differentiated neurons, J Neurosci, 12, 1802, 10.1523/JNEUROSCI.12-05-01802.1992 Greco, 2001, Gene directed enzyme/prodrug therapy of cancer: historical appraisal and future prospectives, J Cell Physiol, 187, 22, 10.1002/1097-4652(2001)9999:9999<::AID-JCP1060>3.0.CO;2-H Freeman, 2000, Suicide gene therapy, Adv Exp Med Biol, 465, 411, 10.1007/0-306-46817-4_36 Moolten, 1994, Drug sensitivity (‘suicide’) genes for selective cancer chemotherapy, Cancer Gene Ther, 1, 279 Kirschstein R, Skirboll L. Stem cells: scientific progress and future research directions. National Institutes of Health, Department of Health and Human Services, 2001. www.stemcells.nih.gov/stemcell/scireport.asp. Food and Drug Administration, Center for Biologics Evaluation and Research, 27th Meeting of the Biological Response Modifiers Advisory Committee; 2000, July 13-14; Gaithersburg, Maryland. www.fda.gov/ohrms/dockets/ac/cber00.htm. Erdo, 2003, Host-dependent tumorigenesis of embryonic stem cell transplantation in experimental stroke, J Cereb Blood Flow Metab, 23, 780, 10.1097/01.WCB.0000071886.63724.FB Bonfil, 1994, Stimulation of angiogenesis as an explanation of Matrigel-enhanced tumor- igenicity, Int J Cancer, 58, 233, 10.1002/ijc.2910580215 Pretlow, 1991, Transplantation of human prostatic carcinoma into nude mice in Matrigel, Cancer Res, 51, 3814 Fridman, 1992, Malignant transforma tion of NIH-3T3 cells after subcutaneous co-injection with a reconstituted basement membrane (matrigel), Int J Cancer, 51, 740, 10.1002/ijc.2910510513 Noel, 1993, Enhancement of tumorigenicity of human breast adenocarcinoma cells in nude mice by matrigel and fibroblasts, Br J Cancer, 68, 909, 10.1038/bjc.1993.453 Topley, 1993, Effect of reconstituted basement membrane components on the growth of a panel of human tumour cell lines in nude mice, Br J Cancer, 67, 953, 10.1038/bjc.1993.176 Fridman, 1991, Enhanced tumor growth of both primary and established human and murine tumor cells in athymic mice after coinjection with Matrigel, J Natl Cancer Inst, 83, 769, 10.1093/jnci/83.11.769