Division of Cellular and Gene Therapies
Office of Cellular, Tissue, and Gene Therapies,
US FDA Center for Biologics Evaluation and Research

Background:
B.S., University of Maryland; College Park
Ph.D., University of Maryland; College Park
Previous Employment:  Basel Institute for Immunology (1986-1991)

Research Interests:
Human adult mesenchymal stem cells (hMSC) are currently used in clinical trials for many clinical indications including heart, bone, and spinal cord repair, improved bone marrow reconstitution, and treatment of inflammatory diseases.  In addition, hMSCs have been proposed for treatment of gastrointestinal effects of acute radiation syndrome.  MSCs will play an important role in the rapidly advancing fields of regenerative medicine and cell-based therapies that aim to repair, replace, restore, or regenerate cells, tissues and organs damaged by disease, injury, or aging.  Manufacturing of large numbers of cells outside the natural environment of the human body may lead to ineffective or dangerous cells, so it is important to understand and carefully control the production process and to define measures that reliably predict safety and efficacy of the MSC-based products.
Current methods to characterize hMSCs rely on a few cell surface markers combined with qualitative, imprecise measures of cell activity.

FDA Fellows participating in this training program will focus on the biology of mesenchymal stem cells and use of this knowledge for development of improved ways to predict safety and efficacy of their use in cell-based therapies.  Our laboratory uses both mouse and human mesenchymal stem cells to study development of mesenchymal stem cells as well as interactions between MSCs and their microenvironment both inside and outside of the body. Such interactions determine if a stem cell will develop normally and safely.  The goal of this project is to develop better characterization assays for mesenchymal stem cell products, particularly potency, with the goal of improving product quality and thus efficacy.

Selected Recent Publications (1-6):

1. Dlk1 influences differentiation and function of B-lymphocytes. Ramadevi Raghunandan, R., Ruiz-Hidalgo, M., Ettinger, R., Rudikoff, E., Riggins, P.S., Farnsworth, R., Laborda, J., and Bauer, S.R. Stem Cells and Development 17:495-507 (2008)
2. Predictors of Acquired Lipodystrophy in Juvenile Dermatomyositis, A Gradient of Sequelae. Bingham A,  Mamyrova G,  Rother, KI, Oral, E,  Cochran, E, Premkumar A., Kleiner D, James- Newton L, Targoff IN, Pandey JP, Mercatante D, Carrick P, Sebring N,  O’Hanlon TP, Ruiz-Hidalgo M,  Turner M, Gordon L,  Laborda J, Bauer SR, Blackshear PJ, Imundo L, Miller FW, Rider LG. Medicine 8: 70-86 (2008)
3. Chronic lymphocytic leukemia overview.  Caporaso, N.,  Goldin, L., Plass, C.,  Calin, G.,  Marti, G., Bauer, S., Raveche, E., McMaster, M.L., Ng, D., Landgren, O., and Slager, S.  British Journal of Haematology 193: 630-634 (2007)
4. Letterio, J., Voong, Nga,  Rudikoff, E.,  and  Bauer, S.R. 2006. Transforming growth factor- sensitivity is altered in abl-myc and raf-myc-induced mouse pre-B cell tumors.  Stem Cells 24: 2611-2617. (2006)
5. Hilbert, D.M., Theisen, P.W., Rudikoff, E.H., and Bauer, S.R.  Interaction of abl and raf with IL-7 signalling pathway and transformation of pre-B cells from resistant mice.  Oncogene  17: 2125-2135 (1998)
6. Bauer, S. R , Ruiz-Hidalgo, M.J,  Rudikoff, E.K., Goldstein, J.,  and Laborda, J.    Modulated expression of the epidermal growth factor-like homeotic protein dlk influences stromal-cell-Pre-B cell interactions, stromal cell adipogenesis, and pre-B-Cell interleukin-7 requirements.  Molec. and Cell. Biol. 18: 5247-5255 (1998)

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