Center for Biologics Evaluation and Research

BIOLOGICAL RESPONSE MODIFIERS ADVISORY COMMITTEE

Meeting #37, March 18-19, 2004

Hilton Hotel, Silver Spring, Maryland

Bibliography:

1. NIH internet web site: http://stemcells.nih.gov/infoCenter/stemCellBasics.asp. Stem cell basics.

2. Wognum, A, Eaves, A, Thomas, T. Identification and isolation of hematopoietic stem cells. Arch Med Res 2003;34:461-475.

3. Orlic, D, Hill, J, Arai, A. Stem cells for myocardial regeneration. Circ Res 2002;91:1092-1102.

4. Hassink, R, de la Riviere, et. al., Transplantation of cells for cardiac repair. J Am Coll Cardiol 2003;41:711-777.

5. Strauer, B, Brehm, M, et. al., Repair of infarcted myocardium by autologous intracoronary mononuclear bone marrow cell transplantation in humans. Circulation 2002;106:1913-1918.

6. Perin, E, Dohmann, H, et. al., Transendocardial, autologous bone marrow cell transplantation for severe, chronic ischemic heart failure. Circulation 2003;107:2294-2302.

7. Ghostine, S., et al., Long-term efficacy of myoblast transplantation on regional structure and function after myocardial infarction. Circulation, 2002. 106(12 Suppl 1): p. I131-6.

8. Kocher, A.A., et al., Neovascularization of ischemic myocardium by human bone-marrow-derived angioblasts prevents cardiomyocyte apoptosis, reduces remodeling and improves cardiac function. Nat Med, 2001. 7(4): p. 430-6.

9. Unger, E.F., Experimental evaluation of coronary collateral development. Cardiovasc Res, 2001. 49:497-506.

10. Thompson, R.B., et al., Comparison of intracardiac cell transplantation: autologous skeletal myoblasts versus bone marrow cells. Circulation, 2003. 108 Suppl 1: p. II264-71.

11. Naimark, W, Lepore, J, et. al., Adenovirus-catheter compatibility increases gene expression after delivery to porcine myocardium. Hum Gene Ther 2003;14:161-166.

12. Korbling, M, Estrov, Z. Adult stem cells for tissue repair—a new therapeutic concept? N Engl J Med 2003;349:570-582.

13. Rosenthal, N. Prometheus’s vulture and the stem-cell promise. N Engl J Med 2003;349:267-274.

14. Forrester, J, Price, M, Makkar, R. Stem cell repair of infarcted myocardium. Circulation 2003;108:1139-11