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Blood, 15 July 2007, Vol. 110, No. 2, pp. 501-508. Prepublished online as a Blood First Edition Paper on March 29, 2007; DOI 10.1182/blood-2007-01-066522. This Article Full Text Full Text (PDF) Supplemental Figure All Versions of this Article: blood-2007-01-066522v1 110/2/501    most recent Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Sakamoto, N. Articles by Rosenberg, A. S. Search for Related Content PubMed PubMed Citation Articles by Sakamoto, N. Articles by Rosenberg, A. S. Related Collections Immunobiology Clinical Trials and Observations Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  CLINICAL TRIALS AND OBSERVATIONS Bovine apolipoprotein B-100 is a dominant immunogen in therapeutic cell populations cultured in fetal calf serum in mice and humans Norihisa Sakamoto1, Kazuhide Tsuji1,2, Linda M. Muul3, Ann M. Lawler4, Emanuel F. Petricoin5, Fabio Candotti3, Julia A. Metcalf6, Jorge A. Tavel6, H. Clifford Lane6, Walter J. Urba7, Bernard A. Fox7, Ajit Varki8, Joan K. Lunney9, and Amy S. Rosenberg1 1 Division of Therapeutic Proteins, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Bethesda, MD; 2 Department of Dermatology, Okayama University Graduate School of Medicine and Dentistry and Pharmaceutical Sciences, Japan; 3 Genetics and Molecular Biology Branch, National Human Genome Research Institute, National Institutes of Health, Bethesda, MD; 4 Transgenic Mouse Facility and Department of Physiology, Johns Hopkins University, School of Medicine, Baltimore, MD; 5 Center for Applied Proteomics and Molecular Medicine, Department of Molecular and Microbiology, George Mason University, Manassas, VA; 6 Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD; 7 Laboratory of Molecular and Tumor Immunology, Robert W. Franz Cancer Research Center, Earle A. Chiles Research Institute, Providence Portland Medical Center, Portland, OR; 8 Glycobiology Research and Training Center and Departments of Medicine and Cellular and Molecular Medicine, University of California, San Diego; 9 Animal Parasitic Diseases Laboratory, Agricultural Research Service, United States Department of Agriculture, Beltsville, MD Recent studies have demonstrated that cell populations intended for therapeutic purposes that are cultured in heterologous animal products can acquire xenoantigens, potentially limiting their utility. In investigations of the immune response to murine embryonic stem cells, we found that a strong antibody response was generated after the second infusion. Both polyclonal and monoclonal antibody responses, derived from immunized mice, were found to be specific for bovine apolipoprotein B-100, which binds to abundant low-density lipoprotein receptors on the cell surface and is internalized. Here we show that in the majority of patients administered 3 different types of cell-based therapies using cells grown in fetal calf serum-containing media, an antibody response to bovine apolipoprotein B-100 develops after the second infusion and is the dominant specificity. The known and potential clinical effects of such antibodies are discussed. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?

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