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Results: 1 to 20 of 25

1.

The evolution of nonclinical regulatory science: advanced therapy medicinal products as a paradigm.

Vestergaard HT, D'Apote L, Schneider CK, Herberts C.

Mol Ther. 2013 Sep;21(9):1644-8. No abstract available.

PMID:
24137820
[PubMed - indexed for MEDLINE]
2.

Regulation of advanced therapy medicinal products in Europe and the role of academia.

Pearce KF, Hildebrandt M, Greinix H, Scheding S, Koehl U, Worel N, Apperley J, Edinger M, Hauser A, Mischak-Weissinger E, Dickinson AM, Lowdell MW.

Cytotherapy. 2014 Mar;16(3):289-97. doi: 10.1016/j.jcyt.2013.08.003. Epub 2013 Oct 8.

PMID:
24113428
[PubMed - in process]
3.

Concise review: guidance in developing commercializable autologous/patient-specific cell therapy manufacturing.

Eaker S, Armant M, Brandwein H, Burger S, Campbell A, Carpenito C, Clarke D, Fong T, Karnieli O, Niss K, Van't Hof W, Wagey R.

Stem Cells Transl Med. 2013 Nov;2(11):871-83. doi: 10.5966/sctm.2013-0050. Epub 2013 Oct 7. Review.

PMID:
24101671
[PubMed - indexed for MEDLINE]
4.

Business oriented EU human cell and tissue product legislation will adversely impact Member States' health care systems.

Pirnay JP, Vanderkelen A, De Vos D, Draye JP, Rose T, Ceulemans C, Ectors N, Huys I, Jennes S, Verbeken G.

Cell Tissue Bank. 2013 Dec;14(4):525-60. doi: 10.1007/s10561-013-9397-6. Epub 2013 Sep 20.

PMID:
24052113
[PubMed - indexed for MEDLINE]
Free PMC Article
5.

Cell therapy companies make strong progress from October 2012 to March 2013 amid mixed stock market sentiment.

Mason C, Mason J, Culme-Seymour EJ, Bonfiglio GA, Reeve BC.

Cell Stem Cell. 2013 Jun 6;12(6):644-7. doi: 10.1016/j.stem.2013.05.017.

PMID:
23746973
[PubMed - in process]
Free Article
6.

Regulation of stem cell therapies under attack in Europe: for whom the bell tolls.

Bianco P, Barker R, Brüstle O, Cattaneo E, Clevers H, Daley GQ, De Luca M, Goldstein L, Lindvall O, Mummery C, Robey PG, Sattler de Sousa E Brito C, Smith A.

EMBO J. 2013 May 29;32(11):1489-95. doi: 10.1038/emboj.2013.114. Epub 2013 May 3.

PMID:
23644381
[PubMed - indexed for MEDLINE]
Free PMC Article
7.

Gatekeepers and enablers: how drug regulators respond to a challenging and changing environment by moving toward a proactive attitude.

Ehmann F, Papaluca Amati M, Salmonson T, Posch M, Vamvakas S, Hemmings R, Eichler HG, Schneider CK.

Clin Pharmacol Ther. 2013 May;93(5):425-32. doi: 10.1038/clpt.2013.14. Epub 2013 Jan 24.

PMID:
23549149
[PubMed - indexed for MEDLINE]
8.

Understanding regenerative medicine: a commissioner's viewpoint.

Warren V.

Regen Med. 2013 Mar;8(2):227-32. doi: 10.2217/rme.13.5.

PMID:
23477402
[PubMed - indexed for MEDLINE]
Free Article
9.

Potency assay development for cellular therapy products: an ISCT review of the requirements and experiences in the industry.

Bravery CA, Carmen J, Fong T, Oprea W, Hoogendoorn KH, Woda J, Burger SR, Rowley JA, Bonyhadi ML, Van't Hof W.

Cytotherapy. 2013 Jan;15(1):9-19. doi: 10.1016/j.jcyt.2012.10.008. Review.

PMID:
23260082
[PubMed - indexed for MEDLINE]
10.

Tissue engineering and regenerative medicine: recent innovations and the transition to translation.

Fisher MB, Mauck RL.

Tissue Eng Part B Rev. 2013 Feb;19(1):1-13. doi: 10.1089/ten.TEB.2012.0723. Review.

PMID:
23253031
[PubMed - indexed for MEDLINE]
Free PMC Article
11.

Autologous cell therapies: the importance of regulatory oversight.

Werner M, Mayleben T, Van Bokkelen G.

Regen Med. 2012 Nov;7(6 Suppl):100-3. doi: 10.2217/rme.12.90.

PMID:
23210820
[PubMed - indexed for MEDLINE]
12.

Autologous cell therapies: challenges in US FDA regulation.

McAllister TN, Audley D, L'Heureux N.

Regen Med. 2012 Nov;7(6 Suppl):94-7. doi: 10.2217/rme.12.83.

PMID:
23210819
[PubMed - indexed for MEDLINE]
13.

Concise review: cell therapies: the route to widespread adoption.

Foley L, Whitaker M.

Stem Cells Transl Med. 2012 May;1(5):438-47. doi: 10.5966/sctm.2011-0009. Epub 2012 May 9. Review.

PMID:
23197823
[PubMed - indexed for MEDLINE]
Free PMC Article
14.

Cell therapy medicinal product regulatory framework in Europe and its application for MSC-based therapy development.

Ancans J.

Front Immunol. 2012 Aug 14;3:253. doi: 10.3389/fimmu.2012.00253. eCollection 2012.

PMID:
22912639
[PubMed]
Free PMC Article
15.

Adult stem cell therapies walk the line.

DeFrancesco L.

Nat Biotechnol. 2012 Aug;30(8):739-41. doi: 10.1038/nbt.2321. No abstract available.

PMID:
22871705
[PubMed - indexed for MEDLINE]
16.

A decade of cell therapy clinical trials (2000-2010).

Culme-Seymour EJ, Davie NL, Brindley DA, Edwards-Parton S, Mason C.

Regen Med. 2012 Jul;7(4):455-62. doi: 10.2217/rme.12.45. No abstract available.

PMID:
22817619
[PubMed - indexed for MEDLINE]
Free Article
17.

Precision manufacturing for clinical-quality regenerative medicines.

Williams DJ, Thomas RJ, Hourd PC, Chandra A, Ratcliffe E, Liu Y, Rayment EA, Archer JR.

Philos Trans A Math Phys Eng Sci. 2012 Aug 28;370(1973):3924-49. doi: 10.1098/rsta.2011.0049. Review.

PMID:
22802496
[PubMed - indexed for MEDLINE]
18.

Does the FDA have regulatory authority over adult autologous stem cell therapies? 21 CFR 1271 and the emperor's new clothes.

Freeman M, Fuerst M.

J Transl Med. 2012 Mar 26;10:60. doi: 10.1186/1479-5876-10-60.

PMID:
22448812
[PubMed - in process]
Free PMC Article
19.

Korea okays stem cell therapies despite limited peer-reviewed data.

Wohn DY.

Nat Med. 2012 Mar 6;18(3):329. doi: 10.1038/nm0312-329a. No abstract available. Erratum in: Nat Med. 2012 Jul;18(7):995.

PMID:
22395680
[PubMed - indexed for MEDLINE]
20.

Clinical development of advanced therapy medicinal products in Europe: evidence that regulators must be proactive.

Maciulaitis R, D'Apote L, Buchanan A, Pioppo L, Schneider CK.

Mol Ther. 2012 Mar;20(3):479-82. doi: 10.1038/mt.2012.13. No abstract available.

PMID:
22378030
[PubMed - indexed for MEDLINE]
Free PMC Article

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