CGMP-manufactured human induced pluripotent stem cells are available for pre-clinical and clinical applications

Stem Cell Reports

Volumn 5, Issue 4, 2015, Pages 647-659

  Baghbaderani, Behnam Ahmadian ^a   Tian, Xinghui ^a   Neo, Boon Hwa ^a   Burkall, Amy ^a   Dimezzo, Tracy ^a   Sierra, Guadalupe ^b   Zeng, Xianmin ^b,c   Warren, Kim ^a   Kovarcik, Don Paul ^a   Fellner, Thomas ^a   Rao, Mahendra S ^d  

^a Lonza Walkersville Inc   (United States)

^b XCell Science Inc   (United States)

^c BUCK INSTITUTE FOR RESEARCH ON AGING   (United States)

^d Q Therapeutics   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CD34 SELECTION; CELL DIFFERENTIATION; CELL ISOLATION; CELL LINE; CELL MATURATION; CONTROLLED STUDY; GOOD MANUFACTURING PRACTICE; HEALTH CARE FACILITY; HUMAN; HUMAN CELL; HUMAN TISSUE; NONHUMAN; PLURIPOTENT STEM CELL; PRIORITY JOURNAL; PROCESS DEVELOPMENT; UMBILICAL CORD BLOOD; UNITED STATES; BIOLOGICAL THERAPY; BIOTECHNOLOGY; CELL CULTURE TECHNIQUE; CELL REPROGRAMMING TECHNIQUE; CYTOLOGY; GENE TARGETING; INDUCED PLURIPOTENT STEM CELL; METABOLISM; PROCEDURES; STEM CELL TRANSPLANTATION; TISSUE BANK;

BIOTECHNOLOGY; CELL CULTURE TECHNIQUES; CELL DIFFERENTIATION; CELL LINE; CELL- AND TISSUE-BASED THERAPY; CELLULAR REPROGRAMMING TECHNIQUES; GENE TARGETING; HUMANS; INDUCED PLURIPOTENT STEM CELLS; STEM CELL TRANSPLANTATION; TISSUE BANKS;

EID: 84944386970     PISSN: 22136711     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.stemcr.2015.08.015     Document Type: Article

References (33)

1. J. Ancans Cell therapy medicinal product regulatory framework in Europe and its application for MSC-based therapy development Front. Immunol. 3 2012 253
2. P.W. Andrews, J. Cavagnaro, R. Deans, E. Feigal, E. Horowitz, A. Keating, M. Rao, M. Turner, I. Wilmut, and S. Yamanaka Harmonizing standards for producing clinical-grade therapies from pluripotent stem cells Nat. Biotechnol. 32 2014 724 726
3. P.W. Andrews, D. Baker, N. Benvinisty, B. Miranda, K. Bruce, O. Brüstle, M. Choi, Y.M. Choi, J.M. Crook, P.A. de Sousa, and et al. Points to consider in the development of seed stocks of pluripotent stem cells for clinical applications: International Stem Cell Banking Initiative (ISCBI) Regen. Med. 10 2, Suppl 2015 1 44
4. M.K. Carpenter, and M.S. Rao Concise review: making and using clinically compliant pluripotent stem cell lines Stem Cells Transl. Med. 4 2015 381 388
5. G. Chen, D.R. Gulbranson, Z. Hou, J.M. Bolin, V. Ruotti, M.D. Probasco, K. Smuga-Otto, S.E. Howden, N.R. Diol, N.E. Propson, and et al. Chemically defined conditions for human iPSC derivation and culture Nat. Methods 8 2011 424 429
6. V.C. Chen, S.M. Couture, J. Ye, Z. Lin, G. Hua, H.-I.P. Huang, J. Wu, D. Hsu, M.K. Carpenter, and L.A. Couture Scalable GMP compliant suspension culture system for human ES cells Stem Cell Res. (Amst.) 8 2012 388 402
7. B.K. Chou, P. Mali, X. Huang, Z. Ye, S.N. Dowey, L.M. Resar, C. Zou, Y.A. Zhang, J. Tong, and L. Cheng Efficient human iPS cell derivation by a non-integrating plasmid from blood cells with unique epigenetic and gene expression signatures Cell Res. 21 2011 518 529
8. B.K. Chou, H. Gu, Y. Gao, S.N. Dowey, Y. Wang, J. Shi, Y. Li, Z. Ye, T. Cheng, and L. Cheng A facile method to establish human induced pluripotent stem cells from adult blood cells under feeder-free and xeno-free culture conditions: a clinically compliant approach Stem Cells Transl. Med. 4 2015 320 332
9. J.M. Crook, T.T. Peura, L. Kravets, A.G. Bosman, J.J. Buzzard, R. Horne, H. Hentze, N.R. Dunn, R. Zweigerdt, F. Chua, and et al. The generation of six clinical-grade human embryonic stem cell lines Cell Stem Cell 1 2007 490 494
10. S.N. Dowey, X. Huang, B.K. Chou, Z. Ye, and L. Cheng Generation of integration-free human induced pluripotent stem cells from postnatal blood mononuclear cells by plasmid vector expression Nat. Protoc. 7 2012 2013 2021
11. C. Ellerström, R. Strehl, K. Moya, K. Andersson, C. Bergh, K. Lundin, J. Hyllner, and H. Semb Derivation of a xeno-free human embryonic stem cell line Stem Cells 24 2006 2170 2176
12. P.J. Fairchild Taming the lion: the challenge of immunity in regenerative medicine Regen. Med. 10 2015 227 229
13. P.A. Goh, S. Caxaria, C. Casper, C. Rosales, T.T. Warner, P.J. Coffey, and A.C. Nathwani A systematic evaluation of integration free reprogramming methods for deriving clinically relevant patient specific induced pluripotent stem (iPS) cells PLoS ONE 8 2013 e81622
14. J.K. Ichida, J. Blanchard, K. Lam, E.Y. Son, J.E. Chung, D. Egli, K.M. Loh, A.C. Carter, F.P. Di Giorgio, K. Koszka, and et al. A small-molecule inhibitor of tgf-β signaling replaces sox2 in reprogramming by inducing nanog Cell Stem Cell 5 2009 491 503
15. J. Lee, N. Sayed, A. Hunter, K.F. Au, W.H. Wong, E.S. Mocarski, R.R. Pera, E. Yakubov, and J.P. Cooke Activation of innate immunity is required for efficient nuclear reprogramming Cell 151 2012 547 558
16. J. Lowenthal, S. Lipnick, M. Rao, and S.C. Hull Specimen collection for induced pluripotent stem cell research: harmonizing the approach to informed consent Stem Cells Transl. Med. 1 2012 409 421
17. A.A. Mack, S. Kroboth, D. Rajesh, and W.B. Wang Generation of induced pluripotent stem cells from CD34+ cells across blood drawn from multiple donors with non-integrating episomal vectors PLoS ONE 6 2011 e27956
18. N. Malik, and M.S. Rao A review of the methods for human iPSC derivation Methods Mol. Biol. 997 2013 23 33
19. O. Momčilović, Q. Liu, A. Swistowski, T. Russo-Tait, Y. Zhao, M.S. Rao, and X. Zeng Genome wide profiling of dopaminergic neurons derived from human embryonic and induced pluripotent stem cells Stem Cells Dev. 23 2014 406 420
20. Y. Nie, P. Walsh, D.L. Clarke, J.A. Rowley, and T. Fellner Scalable passaging of adherent human pluripotent stem cells PLoS ONE 9 2014 e88012
21. K. Okita, Y. Matsumura, Y. Sato, A. Okada, A. Morizane, S. Okamoto, H. Hong, M. Nakagawa, K. Tanabe, K. Tezuka, and et al. A more efficient method to generate integration-free human iPS cells Nat. Methods 8 2011 409 412
22. Y. Pei, G. Sierra, R. Sivapatham, A. Swistowski, M.S. Rao, and X. Zeng A platform for rapid generation of single and multiplexed reporters in human iPSC lines Sci. Rep. 5 2015 9205
23. M. Rao Scalable human ES culture for therapeutic use: propagation, differentiation, genetic modification and regulatory issues Gene Ther. 15 2008 82 88
24. M. Rao, and M.L. Condic Alternative sources of pluripotent stem cells: scientific solutions to an ethical dilemma Stem Cells Dev. 17 2008 1 10
25. M. Rao, L. Ahrlund-Richter, and D.S. Kaufman Concise review: Cord blood banking, transplantation and induced pluripotent stem cell: success and opportunities Stem Cells 30 2012 55 60
26. T.M. Schlaeger, L. Daheron, T.R. Brickler, S. Entwisle, K. Chan, A. Cianci, A. DeVine, A. Ettenger, K. Fitzgerald, M. Godfrey, and et al. A comparison of non-integrating reprogramming methods Nat. Biotechnol. 33 2015 58 63
27. S.D. Schwartz, J.P. Hubschman, G. Heilwell, V. Franco-Cardenas, C.K. Pan, R.M. Ostrick, E. Mickunas, R. Gay, I. Klimanskaya, and R. Lanza Embryonic stem cell trials for macular degeneration: a preliminary report Lancet 379 2012 713 720
28. A. Shaltouki, R. Sivapatham, Y. Pei, A.A. Gerencser, O. Momčilović, M.S. Rao, and X. Zeng Mitochondrial alterations by PARKIN in dopaminergic neurons using PARK2 patient-specific and PARK2 knockout isogenic iPSC lines Stem Cell Reports 4 2015 847 859
29. S. Solomon, F. Pitossi, and M.S. Rao Banking on iPSC - is it doable and is it worthwhile Stem Cell Rev. 11 2015 1 10
30. G.N. Stacey, J.M. Crook, D. Hei, and T. Ludwig Banking human induced pluripotent stem cells: lessons learned from embryonic stem cells? Cell Stem Cell 13 2013 385 388
31. A. Swistowski, J. Peng, Q. Liu, P. Mali, M.S. Rao, L. Cheng, and X. Zeng Efficient generation of functional dopaminergic neurons from human induced pluripotent stem cells under defined conditions Stem Cells 28 2010 1893 1904
32. S.E. Tannenbaum, T.T. Turetsky, O. Singer, E. Aizenman, S. Kirshberg, N. Ilouz, Y. Gil, Y. Berman-Zaken, T.S. Perlman, N. Geva, and et al. Derivation of xeno-free and GMP-grade human embryonic stem cells - platforms for future clinical applications PLoS ONE 7 2012 e35325
33. M. Turner, S. Leslie, N.G. Martin, M. Peschanski, M. Rao, C.J. Taylor, A. Trounson, D. Turner, S. Yamanaka, and I. Wilmut Toward the development of a global induced pluripotent stem cell library Cell Stem Cell 13 2013 382 384