Page 27 - 83_04

Caroline Ruth Weinstein-Oppenheimer et al.

Guideline on human cell-based medicinal products.
EMEA/CHMP/410869/2006. 2006.

59. Commission Directive 2003/63/EC. Eudralex Volume
2B, Notice To Applicant, part II-V?: virological
documentation. 2003.

60. Mizuno H, Tobita M, Uysal A. Concise review:
adiposederived stem cells as a novel tool for future
regenerative medicine. Stem Cells. 2012;30(5):804–
10.

61. Asher D. Bovine sera used in the manufacture of
biologicals: current concerns and policies of the U.S.
Food and Drug Administration regarding the
transmissible spongiform encephalopathies. Dev Biol
Stand. 1999;99:41–4.

62. Committee for Medicinal Products for Human Use.
Note for guidance on the use of bovine serum in the
manufacture of human biological medicinal products.
EMA/CHMP/BWP/457920/2012. 2012.

63. Gould Halme D, Kessler DA. Health Policy Report:
FDA Regulation of Stem Cell Based Therapies. N
Engl J Med. 2006;355:1730–5.

64. Zuk PA, Zhu M, Ashjian P, De Ugarte DA, Huang JI,
Mizuno H, et al. Human Adipose Tissue Is a Source
of Multipotent Stem Cells. Mol Biol Cell.
2002;13(12):4279–95.

65. Zannettino A, Patron S, Arthur A, Khor F, Itescu S,
Gumble J, et al. Multipotential human adipose-derived
stromal stem cells exhibit a perivascular phenotype in
vitro and in vivo. J Cell Physiol. 2008;214(2):413–21.

?

402 @Real Academia Nacional de Farmacia. Spain