-
1
-
-
34249826621
-
Translational regenerative medicine research: Essential to discovery and outcome
-
DOI 10.2217/17460751.2.3.227
-
Mason C, Dunnill P. Translational regenerative medicine research: essential to discovery and outcome. Regen. Med. 2(3), 227-229 (2007). (Pubitemid 46845883)
-
(2007)
Regenerative Medicine
, vol.2
, Issue.3
, pp. 227-229
-
-
Mason, C.1
Dunnill, P.2
-
2
-
-
79953060593
-
Therapies of tomorrow require more than factories from the past
-
James D. Therapies of tomorrow require more than factories from the past. Bioproc. Int. 9, 4-11 (2011).
-
(2011)
Bioproc. Int.
, vol.9
, pp. 4-11
-
-
James, D.1
-
3
-
-
34249743748
-
Regenerative medicine bioprocessing: The need to learn from the experience of other fields
-
Mason C, Hoare M. Regenerative medicine bioprocessing: the need to learn from the experience of other fields. Regen. Med. 1(5), 615-623 (2006).
-
(2006)
Regen. Med.
, vol.1
, Issue.5
, pp. 615-623
-
-
Mason, C.1
Hoare, M.2
-
4
-
-
78649840480
-
Regulating interface science healthcare products: Myths and uncertainties
-
Bravery C. Regulating interface science healthcare products: myths and uncertainties. J. R. Soc. Interface 7, 7 (2010).
-
(2010)
J. R. Soc. Interface
, vol.7
, pp. 7
-
-
Bravery, C.1
-
5
-
-
79955140577
-
Cell therapy bioprocessing integrating process and product development for the next generation of biotherapeutics
-
Brandenberger R, Burger S, Campbell A, Fong T, Lapinskas E, Rowley J. Cell therapy bioprocessing integrating process and product development for the next generation of biotherapeutics. Bioproc. Int. 9(Suppl. 1), 30-37 (2011).
-
(2011)
Bioproc. Int.
, vol.9
, Issue.1
, pp. 30-37
-
-
Brandenberger, R.1
Burger, S.2
Campbell, A.3
Fong, T.4
Lapinskas, E.5
Rowley, J.6
-
6
-
-
70349582553
-
Regenerative medicine glossary
-
Regenerative medicine glossary. Regen. Med. 4(Suppl. 4), S1-S88 (2009).
-
(2009)
Regen. Med.
, vol.4
, Issue.4
-
-
-
7
-
-
77952536406
-
Concise review mind the gap: Challenges in characterizing and quantifying cell- and tissue-based therapies for clinical translation
-
Rayment EA, Williams DJ. Concise review. Mind the gap: challenges in characterizing and quantifying cell- and tissue-based therapies for clinical translation. Stem Cells 28(5), 996-1004 (2010).
-
(2010)
Stem Cells
, vol.28
, Issue.5
, pp. 996-1004
-
-
Rayment, E.A.1
Williams, D.J.2
-
8
-
-
83655208265
-
-
US FDA. Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs). US Department of Health and Human Services, Rockville, MD, USA
-
US FDA. Guidance for FDA Reviewers and Sponsors. Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs). US Department of Health and Human Services, Rockville, MD, USA, 1, 1-39 (2008).
-
(2008)
Guidance for FDA Reviewers and Sponsors
, vol.1
, pp. 1-39
-
-
-
9
-
-
83655177215
-
FDA summary for basis of approval
-
BLA Ref No. 96- 0372
-
FDA summary for basis of approval: BLA Ref No. 96-0372, Carticel.
-
Carticel
-
-
-
10
-
-
77955351993
-
Fluorescence-activated cell sorting for CGMP processing of therapeutic cells
-
Mcintyre C, Flyg B, Fong T. Fluorescence-activated cell sorting for CGMP processing of therapeutic cells. Bioproc. Int. 8, 44-53 (2010).
-
(2010)
Bioproc. Int.
, vol.8
, pp. 44-53
-
-
Mcintyre, C.1
Flyg, B.2
Fong, T.3
-
11
-
-
0346014707
-
Performance of plate-based cytokine flow cytometry with automated data analysis
-
Suni MA, Dunn HS, Orr PL et al. Performance of plate-based cytokine flow cytometry with automated data analysis. BMC Immunol. 4, 9 (2003).
-
(2003)
BMC Immunol.
, vol.4
, pp. 9
-
-
Suni, M.A.1
Dunn, H.S.2
Orr, P.L.3
-
12
-
-
68549096121
-
Global transcriptional analysis for biomarker discovery and validation in cellular therapies
-
Stroncek DF, Jin P, Wang E, Ren J, Sabatino M, Marincola FM. Global transcriptional analysis for biomarker discovery and validation in cellular therapies. Mol. Diagn. Ther. 13(3), 181-193 (2009).
-
(2009)
Mol. Diagn. Ther.
, vol.13
, Issue.3
, pp. 181-193
-
-
Stroncek, D.F.1
Jin, P.2
Wang, E.3
Ren, J.4
Sabatino, M.5
Marincola, F.M.6
-
13
-
-
63049103432
-
A study of microRNAs in silico and in vivo: Emerging regulators of embryonic stem cells
-
Kim KS, Kim JS, Lee MR, Jeong HS, Kim J. A study of microRNAs in silico and in vivo: emerging regulators of embryonic stem cells. FEBS J. 276(8), 2140-2149 (2009).
-
(2009)
FEBS J.
, vol.276
, Issue.8
, pp. 2140-2149
-
-
Kim, K.S.1
Kim, J.S.2
Lee, M.R.3
Jeong, H.S.4
Kim, J.5
-
14
-
-
28644448149
-
Efficient differentiation of human embryonic stem cells to definitive endoderm
-
DOI 10.1038/nbt1163
-
D'amour KA, Agulnick AD, Eliazer S, Kelly OG, Kroon E, Baetge EE. Efficient differentiation of human embryonic stem cells to definitive endoderm. Nat. Biotechnol. 23(12), 1534-1541 (2005). (Pubitemid 41752931)
-
(2005)
Nature Biotechnology
, vol.23
, Issue.12
, pp. 1534-1541
-
-
D'Amour, K.A.1
Agulnick, A.D.2
Eliazer, S.3
Kelly, O.G.4
Kroon, E.5
Baetge, E.E.6
-
15
-
-
58449135981
-
Why are MSCs therapeutic new data: New insight
-
Caplan AI. Why are MSCs therapeutic? New data: new insight. J. Pathol. 217(2), 318-324 (2009).
-
(2009)
J. Pathol.
, vol.217
, Issue.2
, pp. 318-324
-
-
Caplan, A.I.1
-
16
-
-
33749334622
-
Human progenitor cells from bone marrow or adipose tissue produce VEGF, HGF, and IGF-I in response to TNF by a p38 MAPK-dependent mechanism
-
DOI 10.1152/ajpregu.00280.2006
-
Wang M, Crisostomo PR, Herring C, Meldrum KK, Meldrum DR. Human progenitor cells from bone marrow or adipose tissue produce VEGF, HGF, and IGF I in response to TNF by a p38 MAPK-dependent mechanism. Am. J. Physiol. Regul. Integr. Comp. Physiol. 291(4), R880-R884 (2006). (Pubitemid 44498426)
-
(2006)
American Journal of Physiology - Regulatory Integrative and Comparative Physiology
, vol.291
, Issue.4
-
-
Wang, M.1
Crisostomo, P.R.2
Herring, C.3
Meldrum, K.K.4
Meldrum, D.R.5
-
17
-
-
83655161484
-
-
US FDA. US Department of Health and Human Services, Rockville, MD, USA
-
US FDA. Final Guidance for Industry. Potency Tests for Cellular and Gene Therapy Products. US Department of Health and Human Services, Rockville, MD, USA, 1, 1-19 (2011).
-
(2011)
Final Guidance for Industry. Potency Tests for Cellular and Gene Therapy Products
, vol.1
, pp. 1-19
-
-
-
18
-
-
31744440551
-
Cytokine interactions in mesenchymal stem cells from cord blood
-
Liu CH, Hwang SM. Cytokine interactions in mesenchymal stem cells from cord blood. Cytokine 32(6), 270-279 (2005).
-
(2005)
Cytokine
, vol.32
, Issue.6
, pp. 270-279
-
-
Liu, C.H.1
Hwang, S.M.2
-
19
-
-
77958572322
-
Mesenchymal stem cells: Mechanisms of immunomodulation and homing
-
Yagi H, Soto-Gutierrez A, Parekkadan B et al. Mesenchymal stem cells: mechanisms of immunomodulation and homing. Cell Transplant. 19(6), 667-679 (2010).
-
(2010)
Cell Transplant.
, vol.19
, Issue.6
, pp. 667-679
-
-
Yagi, H.1
Soto-Gutierrez, A.2
Parekkadan, B.3
-
20
-
-
63849112500
-
The role of indoleamine 2 3 dioxygenase in the induction of immune tolerance: Focus on hematology
-
Curti A, Trabanelli S, Salvestrini V, Baccarani M, Lemoli RM. The role of indoleamine 2,3 dioxygenase in the induction of immune tolerance: focus on hematology. Blood 113(11), 2394-2401 (2009).
-
(2009)
Blood
, vol.113
, Issue.11
, pp. 2394-2401
-
-
Curti, A.1
Trabanelli, S.2
Salvestrini, V.3
Baccarani, M.4
Lemoli, R.M.5
-
21
-
-
33747713246
-
Minimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement
-
DOI 10.1080/14653240600855905, PII Q2183N8UT042W62H
-
Dominici M, Le Blanc K, Mueller I et al. Minimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement. Cytotherapy 8(4), 315-317 (2006). (Pubitemid 44269669)
-
(2006)
Cytotherapy
, vol.8
, Issue.4
, pp. 315-317
-
-
Dominici, M.1
Le Blanc, K.2
Mueller, I.3
Slaper-Cortenbach, I.4
Marini, F.C.5
Krause, D.S.6
Deans, R.J.7
Keating, A.8
Prockop, D.J.9
Horwitz, E.M.10
-
23
-
-
57149109777
-
Instant stem cell therapy: Characterization and concentration of human mesenchymal stem cells in vitro
-
Kasten P, Beyen I, Egermann M et al. Instant stem cell therapy: characterization and concentration of human mesenchymal stem cells in vitro. Eur. Cell. Mater. 16, 47-55 (2008).
-
(2008)
Eur. Cell. Mater.
, vol.16
, pp. 47-55
-
-
Kasten, P.1
Beyen, I.2
Egermann, M.3
-
24
-
-
18744371337
-
+ cells and CFU-GM with time to hematopoietic engraftment
-
DOI 10.1038/sj.bmt.1704926
-
+ cells and CFU-GM with time to hematopoietic engraftment. Bone Marrow Transplant. 35(9), 881-887 (2005). (Pubitemid 40667630)
-
(2005)
Bone Marrow Transplantation
, vol.35
, Issue.9
, pp. 881-887
-
-
Yang, H.1
Acker, J.P.2
Cabuhat, M.3
Letcher, B.4
Larratt, L.5
McGann, L.E.6
-
25
-
-
69049089212
-
Tissue repair cells for the treatment of cardiovascular diseases
-
Goltry K, Rowley J, Peters M, Burchardt E. Tissue repair cells for the treatment of cardiovascular diseases. Adv. Mol. Med. 3(1), 9 (2007).
-
(2007)
Adv. Mol. Med.
, vol.3
, Issue.1
, pp. 9
-
-
Goltry, K.1
Rowley, J.2
Peters, M.3
Burchardt, E.4
-
26
-
-
24944447970
-
Validation and development of a predictive paradigm for hemotoxicology using a multifunctional bioluminescence colony-forming proliferation assay
-
DOI 10.1093/toxsci/kfi250
-
Rich IN, Hall KM. Validation and development of a predictive paradigm for hemotoxicology using a multifunctional bioluminescence colony forming proliferation assay. Toxicol. Sci. 87(2), 427-441 (2005). (Pubitemid 41300690)
-
(2005)
Toxicological Sciences
, vol.87
, Issue.2
, pp. 427-441
-
-
Rich, I.N.1
Hall, K.M.2
-
27
-
-
33846423521
-
Oligodendrocyte progenitor cells derived from human embryonic stem cells express neurotrophic factors
-
DOI 10.1089/scd.2006.15.943
-
Zhang YW, Denham J, Thies RS. Oligodendrocyte progenitor cells derived from human embryonic stem cells express neurotrophic factors. Stem Cells Dev. 15(6), 943-952 (2006). (Pubitemid 46147864)
-
(2006)
Stem Cells and Development
, vol.15
, Issue.6
, pp. 943-952
-
-
Zhang, Y.W.1
Denham, J.2
Thies, R.S.3
-
28
-
-
41849151748
-
Pancreatic endoderm derived from human embryonic stem cells generates glucose-responsive insulin-secreting cells in vivo
-
DOI 10.1038/nbt1393, PII NBT1393
-
Kroon E, Martinson LA, Kadoya K et al. Pancreatic endoderm derived from human embryonic stem cells generates glucose-responsive insulin-secreting cells in vivo. Nat. Biotechnol. 26(4), 443-452 (2008). (Pubitemid 351501814)
-
(2008)
Nature Biotechnology
, vol.26
, Issue.4
, pp. 443-452
-
-
Kroon, E.1
Martinson, L.A.2
Kadoya, K.3
Bang, A.G.4
Kelly, O.G.5
Eliazer, S.6
Young, H.7
Richardson, M.8
Smart, N.G.9
Cunningham, J.10
Agulnick, A.D.11
D'Amour, K.A.12
Carpenter, M.K.13
Baetge, E.E.14
-
29
-
-
6344287506
-
Derivation and comparative assessment of retinal pigment epithelium from human embryonic stem cells using transcriptomics
-
DOI 10.1089/clo.2004.6.217
-
Klimanskaya I, Hipp J, Rezai KA, West M, Atala A, Lanza R. Derivation and comparative assessment of retinal pigment epithelium from human embryonic stem cells using transcriptomics. Cloning Stem Cells 6(3), 217-245 (2004). (Pubitemid 39391307)
-
(2004)
Cloning and Stem Cells
, vol.6
, Issue.3
, pp. 217-245
-
-
Klimanskaya, I.1
Hipp, J.2
Rezai, K.A.3
West, M.4
Atala, A.5
Lanza, R.6
-
30
-
-
75749147077
-
Antibody-based protein multiplex platforms: Technical and operational challenges
-
Ellington AA, Kullo IJ, Bailey KR, Klee GG. Antibody-based protein multiplex platforms: technical and operational challenges. Clin. Chem. 56(2), 186-193 (2009).
-
(2009)
Clin. Chem.
, vol.56
, Issue.2
, pp. 186-193
-
-
Ellington, A.A.1
Kullo, I.J.2
Bailey, K.R.3
Klee, G.G.4
-
31
-
-
79957856719
-
Assessing the safety of stem cell therapeutics
-
Goldring CE, Duffy PA, Benvenisty N et al. Assessing the safety of stem cell therapeutics. Cell Stem Cell 8(6), 618-628 (2011).
-
(2011)
Cell Stem Cell
, vol.8
, Issue.6
, pp. 618-628
-
-
Goldring, C.E.1
Duffy, P.A.2
Benvenisty, N.3
-
32
-
-
0037317086
-
Demystified human endogenous retroviruses
-
Nelson PN, Carnegie PR, Martin J et al. Demystified. Human endogenous retroviruses. Mol. Pathol. 56(1), 11-18 (2003).
-
(2003)
Mol. Pathol.
, vol.56
, Issue.1
, pp. 11-18
-
-
Nelson, P.N.1
Carnegie, P.R.2
Martin, J.3
-
33
-
-
10644257398
-
Human endogenous retroviruses in health and disease: A symbiotic perspective
-
DOI 10.1258/jrsm.97.12.560
-
Ryan FP. Human endogenous retroviruses in health and disease: a symbiotic perspective. J. R. Soc. Med. 97(12), 560-565 (2004). (Pubitemid 39656944)
-
(2004)
Journal of the Royal Society of Medicine
, vol.97
, Issue.12
, pp. 560-565
-
-
Ryan, F.P.1
-
34
-
-
83655208266
-
-
International Conference on Harmonisation. EMEA, Canary Wharf, London, UK
-
International Conference on Harmonisation. Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin. EMEA, Canary Wharf, London, UK, 1, 1-33 (2006).
-
(2006)
Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin
, vol.1
, pp. 1-33
-
-
-
35
-
-
77957981209
-
Adoptive cell therapy: Genetic modification to redirect effector cell specificity
-
Morgan RA, Dudley ME, Rosenberg SA. Adoptive cell therapy: genetic modification to redirect effector cell specificity. Cancer J. 16(4), 336-341 (2010).
-
(2010)
Cancer J.
, vol.16
, Issue.4
, pp. 336-341
-
-
Morgan, R.A.1
Dudley, M.E.2
Rosenberg, S.A.3
-
36
-
-
83655177210
-
-
US FDA. US Department of Health and Human Services, Rockville, MD, USA
-
US FDA. Guidance for Industry. Guidance for Human Somatic Cell Therapy and Gene Therapy. US Department of Health and Human Services, Rockville, MD, USA, 1, 30 (1998).
-
(1998)
Guidance for Industry. Guidance for Human Somatic Cell Therapy and Gene Therapy
, vol.1
, pp. 30
-
-
-
38
-
-
67650506083
-
Developing safe therapies from human pluripotent stem cells
-
Carpenter MK, Frey-Vasconcells J, Rao MS. Developing safe therapies from human pluripotent stem cells. Nat. Biotechnol. 27(7), 606-613 (2009).
-
(2009)
Nat. Biotechnol.
, vol.27
, Issue.7
, pp. 606-613
-
-
Carpenter, M.K.1
Frey-Vasconcells, J.2
Rao, M.S.3
-
39
-
-
77957935775
-
Geron trial resumes but standards for stem cell trials remain elusive
-
Strauss S. Geron trial resumes, but standards for stem cell trials remain elusive. Nat. Biotechnol. 28(10), 989-990 (2010).
-
(2010)
Nat. Biotechnol.
, vol.28
, Issue.10
, pp. 989-990
-
-
Strauss, S.1
-
40
-
-
52449113892
-
Similar biological characteristics of human embryonic stem cell lines with normal and abnormal karyotypes
-
Sun X, Long X, Yin Y et al. Similar biological characteristics of human embryonic stem cell lines with normal and abnormal karyotypes. Hum. Reprod. 23(10), 2185-2193 (2008).
-
(2008)
Hum. Reprod.
, vol.23
, Issue.10
, pp. 2185-2193
-
-
Sun, X.1
Long, X.2
Yin, Y.3
-
41
-
-
79952258224
-
Somatic coding mutations in human induced pluripotent stem cells
-
Gore A, Li Z, Fung HL et al. Somatic coding mutations in human induced pluripotent stem cells. Nature 471(7336), 63-67 (2011).
-
(2011)
Nature
, vol.471
, Issue.7336
, pp. 63-67
-
-
Gore, A.1
Li, Z.2
Fung, H.L.3
-
42
-
-
83655208267
-
-
US FDA. US Department of Health and Human Services, Rockville, MD, USA
-
US FDA. Guidance for Industry. Process Validation: General Principles and Practices. US Department of Health and Human Services, Rockville, MD, USA, 1, 1-22 (2011).
-
(2011)
Guidance for Industry Process Validation: General Principles and Practices
, vol.1
, pp. 1-22
-
-
-
43
-
-
83655161481
-
-
International Conference on Harmonisation EMEA, Canary Wharf, London, UK
-
International Conference on Harmonisation. Q5E. Comparability of Biotechnological/ Biological Products Subject to Changes in Their Manufacturing Process. EMEA, Canary Wharf, London, UK, 1, 1-11 (2003).
-
(2003)
Q5E Comparability of Biotechnological/ Biological Products Subject to Changes in Their Manufacturing Process
, vol.1
, pp. 1-11
-
-
-
44
-
-
83655161480
-
-
International Conference on Harmonisation EMEA, Canary Wharf, London, UK
-
International Conference on Harmonisation. Q5C. Guideline for Industry: Quality of Biotechnological Products: Stability Testing of Biotechnological/ Biological Products. EMEA, Canary Wharf, London, UK, 1, 1-12 (1996).
-
(1996)
Q5C Guideline for Industry: Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
, vol.1
, pp. 1-12
-
-
-
45
-
-
49949108324
-
Application of process quality engineering techniques to improve the understanding of the in vitro processing of stem cells for therapeutic use
-
Thomas RJ, Hourd PC, Williams DJ. Application of process quality engineering techniques to improve the understanding of the in vitro processing of stem cells for therapeutic use. J. Biotechnol. 136(3-4), 148-155 (2008).
-
(2008)
J. Biotechnol.
, vol.136
, Issue.3-4
, pp. 148-155
-
-
Thomas, R.J.1
Hourd, P.C.2
Williams, D.J.3
-
46
-
-
59649121198
-
The biopharmaceutical industrys new operating paradigm
-
Julien C, Whitford W. The biopharmaceutical industry's new operating paradigm. Bioproc. Int. 8, 6-14 (2008).
-
(2008)
Bioproc. Int.
, vol.8
, pp. 6-14
-
-
Julien, C.1
Whitford, W.2
-
47
-
-
79956020160
-
Developing cell biomanufacturing processes
-
Rowley J. Developing cell biomanufacturing processes. Chem. Eng. Prog. SBE(Suppl.), 6 (2010).
-
(2010)
Chem. Eng. Prog. SBE
, vol.6
-
-
Rowley, J.1
-
49
-
-
61449505236
-
Genetic and epigenetic instability of human bone marrow mesenchymal stem cells expanded in autologous serum or fetal bovine serum
-
Dahl JA, Duggal S, Coulston N et al. Genetic and epigenetic instability of human bone marrow mesenchymal stem cells expanded in autologous serum or fetal bovine serum. Int. J. Dev. Biol. 52(8), 1033-1042 (2008).
-
(2008)
Int. J. Dev. Biol.
, vol.52
, Issue.8
, pp. 1033-1042
-
-
Dahl, J.A.1
Duggal, S.2
Coulston, N.3
-
50
-
-
27144541524
-
In vitro expansion of human mesenchymal stem cells: Choice of serum is a determinant of cell proliferation, differentiation, gene expression, and transcriptome stability
-
DOI 10.1634/stemcells.2005-0094
-
Shahdadfar A, Fronsdal K, Haug T, Reinholt FP, Brinchmann JE. In vitro expansion of human mesenchymal stem cells: choice of serum is a determinant of cell proliferation, differentiation, gene expression, and transcriptome stability. Stem Cells 23(9), 1357-1366 (2005). (Pubitemid 41504923)
-
(2005)
Stem Cells
, vol.23
, Issue.9
, pp. 1357-1366
-
-
Shahdadfar, A.1
Fronsdal, K.2
Haug, T.3
Reinholt, F.P.4
Brinchmann, J.E.5
|