-
1
-
-
77957322499
-
Techniques for culture and assessment of limbal stem cell grafts
-
Di Iorio E, Ferrari S, Fasolo A, Böhm E, Ponzin D, Barbaro V: Techniques for culture and assessment of limbal stem cell grafts. Ocul Surf 2010; 8: 146-153.
-
(2010)
Ocul Surf
, vol.8
, pp. 146-153
-
-
Di Iorio, E.1
Ferrari, S.2
Fasolo, A.3
Böhm, E.4
Ponzin, D.5
Barbaro, V.6
-
6
-
-
84860993047
-
Cryopreservation of human vascular umbilical cord cells under good manufacturing practice conditions for future cell banks
-
Polchow B, Kebbel K, Schmiedeknecht G, Reichardt A, Henrich W, Hetzer R, Lueders C: Cryopreservation of human vascular umbilical cord cells under good manufacturing practice conditions for future cell banks. J Transl Med 2012; 10: 98.
-
(2012)
J Transl Med
, vol.10
, pp. 98
-
-
Polchow, B.1
Kebbel, K.2
Schmiedeknecht, G.3
Reichardt, A.4
Henrich, W.5
Hetzer, R.6
Lueders, C.7
-
7
-
-
77954788920
-
Regulatory considerations for the development of autologous induced pluripotent stem cell therapies
-
Carpenter MK, Couture LA: Regulatory considerations for the development of autologous induced pluripotent stem cell therapies. Regen Med 2010; 5: 569-579.
-
(2010)
Regen Med
, vol.5
, pp. 569-579
-
-
Carpenter, M.K.1
Couture, L.A.2
-
8
-
-
84872922024
-
Examination of the regulatory frameworks applicable to biologic drugs (including stem cells and their progeny) in Europe
-
the U.S., and Australia. I. A method of manual documentary analysis
-
Ilic N, Savic S, Siegel E, Atkinson K, Tasic L: Examination of the regulatory frameworks applicable to biologic drugs (including stem cells and their progeny) in Europe, the U.S., and Australia. I. A method of manual documentary analysis. Stem Cells Transl Med 2012; 1: 898-908.
-
(2012)
Stem Cells Transl Med
, vol.1
, pp. 898-908
-
-
Ilic, N.1
Savic, S.2
Siegel, E.3
Atkinson, K.4
Tasic, L.5
-
9
-
-
84872946357
-
Examination of the regulatory frameworks applicable to biologic drugs (including stem cells and their progeny) in Europe
-
the U.S., and Australia, II. A method of software documentary analysis
-
Ilic N, Savic S, Siegel E, Atkinson K, Tasic L: Examination of the regulatory frameworks applicable to biologic drugs (including stem cells and their progeny) in Europe, the U.S., and Australia. II. A method of software documentary analysis. Stem Cells Transl Med 2012; 1: 909-920.
-
(2012)
Stem Cells Transl Med
, vol.1
, pp. 909-920
-
-
Ilic, N.1
Savic, S.2
Siegel, E.3
Atkinson, K.4
Tasic, L.5
-
10
-
-
84874217844
-
Cell therapy medicinal product regulatory framework in Europe and its application for MSC-based therapy development
-
Ancans J: Cell therapy medicinal product regulatory framework in Europe and its application for MSC-based therapy development. Front Immunol 2012; 3: 253.
-
(2012)
Front Immunol
, vol.3
, pp. 253
-
-
Ancans, J.1
-
11
-
-
80054099313
-
CAT Secretariat & US Food and Drug Administration
-
European Medicines Agency
-
European Medicines Agency, CAT Secretariat & US Food and Drug Administration. Regen Med 2011; 6(suppl): 90-96.
-
(2011)
Regen Med
, vol.6
, pp. 90-96
-
-
-
12
-
-
77954678396
-
Bone marrow derived stem cells in regenerative medicine as advanced therapy medicinal products
-
Astori G, Soncin S, Lo Cicero V, Siclari F, Sürder D, Turchetto L, Soldati G, Moccetti T: Bone marrow derived stem cells in regenerative medicine as advanced therapy medicinal products. Am J Transl Res 2010; 2: 285-295.
-
(2010)
Am J Transl Res
, vol.2
, pp. 285-295
-
-
Astori, G.1
Soncin, S.2
Lo Cicero, V.3
Siclari, F.4
Sürder, D.5
Turchetto, L.6
Soldati, G.7
Moccetti, T.8
-
13
-
-
2542465496
-
-
Proposed approach to regulation of cellular and tissue-based products
-
Proposed approach to regulation of cellular and tissue-based products. The Food and Drug Administration. 1997. http://www.fda.gov/downloads/ BiologicsBloodVaccines/ Guidance ComplianceRegulatoryInformation/ Guidances/Tissue/UCM062601.pdf.
-
(1997)
The Food and Drug Administration
-
-
-
14
-
-
34547890682
-
Infrastructure development for human cell therapy translation
-
Dietz AB, Padley DJ, Gastineau DA: Infrastructure development for human cell therapy translation. Clin Pharmacol Ther 2007; 82: 320-324.
-
(2007)
Clin Pharmacol Ther
, vol.82
, pp. 320-324
-
-
Dietz, A.B.1
Padley, D.J.2
Gastineau, D.A.3
-
15
-
-
2542465496
-
-
Guidance for Industry, Regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps)-small entity compliance guide
-
Guidance for Industry: Regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps)-small entity compliance guide. The Food and Drug Administration. 2007. http://www. fda.gov/BiologicsBloodVaccines/ Guidan ceComplianceRegulatoryInformation/ Guidances/Tissue/ucm073366.pdf.
-
(2007)
The Food and Drug Administration
-
-
-
16
-
-
84928244111
-
-
Reflection paper on classification of advanced therapy medicinal products. Committee for Advanced Therapies. European Medicines Agency. 2012.
-
Reflection paper on classification of advanced therapy medicinal products. Committee for Advanced Therapies. European Medicines Agency. 2012. http://www.ema.europa.eu/docs/en GB/document-library/Regulatory-and procedural-guideline/2012/04/ WC500126681.pdf.
-
-
-
-
17
-
-
84928244110
-
-
Guide to safety and quality assurance for organs, tissues and cells. Strasbourg, Council of Europe Publishing, ed 2.
-
Guide to safety and quality assurance for organs, tissues and cells. Strasbourg, Council of Europe Publishing, ed 2. 2004. http://www.coe.int/t/dg3/health/ Source/GuideSecurity2-en.pdf.
-
(2004)
-
-
-
18
-
-
84928244109
-
-
Guideline on human cell-based medicinal products. Committee for Medicinal Product for Human Use. European Medicines Agency
-
Guideline on human cell-based medicinal products. Committee for Medicinal Product for Human Use. European Medicines Agency. 2008. http://www. ema.europa.eu/docs/en-GB/document library/Scientific-guideline/2009/09/ WC500003894.pdf.
-
(2008)
-
-
-
19
-
-
84928244108
-
-
Good manufacturing practice (GMP) Guidelines. The rules governing medicinal products in the European Union. EudraLex
-
Good manufacturing practice (GMP) Guidelines. The rules governing medicinal products in the European Union. EudraLex, vol 4, 2011. http://ec.europa. eu/health/documents/eudralex/vol-4/ index-en.htm.
-
(2011)
, vol.4
-
-
|