DESCRIPTION
Autologous cell therapy (i.e., cellular cardiomyoplasty) for the treatment of damaged myocardium has been researched as a technique to either stimulate regeneration of the myocardium or modify ventricular remodeling post-infarction. Skeletal myoblasts harvested from a muscle biopsy and hematopoietic stem cells harvested from bone marrow or peripheral blood have been investigated for this purpose.
Infusion of growth factor (i.e., granulocyte colony stimulating factor [GCSF]) to accelerate the bone marrow's production of hematopoietic stem cells has also been researched as a treatment of damaged myocardium.
POLICY
Autologous cell therapy for the treatment of damaged myocardium, including, but not limited to, the following: skeletal myoblasts and hematopoietic stem cells is considered investigational.
Infusion of growth factors (i.e., granulocyte colony stimulating factor [GCSF]) as a technique to increase the numbers of circulating hematopoietic stem cells for the treatment of damaged myocardium is considered investigational.
ADDITIONAL INFORMATION
Published evidence based studies and support by professional organizations regarding the utilization of autologous cell therapy are lacking.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (7:2008). Autologous progenitor cell therapy for the treatment of damaged myocardium due to ischemia (2.02.18). Retrieved September 29, 2008 from BlueWeb. (28 articles and/or guidelines reviewed)
Gao, L. R., Wang, Z. G., Zhu, Z. M., Fei, Y. X., He, S., Tian, H. T., et al. (2006). Effect of intracoronary transplantation of autologous bone marrow-derived mononuclear cells on outcomes of patients with refractory chronic heart failure secondary to ischemic cardiomyopathy. The American Journal of Cardiology, 98 (5), 597-602.
Kang, H. J., Kim, H. S., Koo, B. K., Kim, Y. J., Lee, D. S., Sohn, D. W., et al. (2007). Intracoronary infusion of the mobilized peripheral blood stem cell by G-CSF is better than mobilization alone by G-CSF for improvement of cardiac function and remodeling: 2-year follow-up results of the Myocardial Regeneration and Angiogenesis in Myocardial Infarction with G-CSF and Intra-Coronary Stem Cell Infusion (MAGIC Cell) 1 trial. American Heart Journal, 98 (5), 597-602. (Level 2 Evidence - Independent study)
Karra, R. & Wu, S. M. (2008). Multipotent stem cells in cardiac regenerative therapy. Regenerative Medicine, 3 (2):189-198.
Meluzın, J., Mayer, J., Groch, L., Janous, S., Hornacek, I., Hlinomaz, O., et al. (2006). Autologous transplantation of mononuclear bone marrow cells in patients with acute myocardial infarction: The effect of the dose of transplanted cells on myocardial function. American Heart Journal, 152 (5), 975 e9-e15. (Level 2 Evidence - Independent study)
Nathan M Novotny, N. M., Ray, R., Markel, T. A., Crisostomo, P. R., Wang, M., Wang, Y., et al. (2008). Stem cell therapy in myocardial repair and remodeling. American College of Surgeons, 207 (3), 423-434.
Schachinger, V., Erbs, S., Elsasser, A., Haberbosch, W., Hambrecht, R., Holschermann, H., et al. (2006). Intracoronary bone marrow-derived progenitor cells in acute myocardial infarction. The New England Journal of Medicine, 355 (12), 1210-1221. (Level 1 Evidence - Industry sponsored)
Schachinger, V., Erbs, S., Elsasser, A., Haberbosch, W., Hambrecht, R., Holschermann, H., et al. (2006). Improved clinical outcome after intracoronary administration of bone marrow-derived progenitor cells in acute myocardial infarction: Final 1-year results of the REPAIR-AMI trial. European Heart Journal, 27 (23), 2775-2783. (Level 1 Evidence - Industry sponsored)
U. S. Food and Drug Administration. (2004, June). Center for Biologics Evaluation and Research. Cellular therapy. Potential treatment for heart disease. Retrieved September 30, 2008 from http://www.fda.gov/cber/genetherapy/celltherapyheart.htm.
ORIGINAL EFFECTIVE DATE: 4/12/2007
MOST RECENT REVIEW DATE: 11/13/2008
ID_BT
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