DESCRIPTION
Progenitor cell therapy is being investigated for the treatment of damaged myocardium resulting from acute or chronic cardiac ischemia. Progenitor cell therapy describes the use of multipotent cells of various cell lineages (autologous or allogeneic) for tissue repair and/or regeneration.
Ischemia is the most common cause of cardiovascular disease and myocardial damage in the developed world. Despite impressive advances in treatment, ischemic heart disease is still associated with high morbidity and mortality. Current treatments for ischemic heart disease seek to revascularize occluded arteries, optimize pump function, and prevent future myocardial damage. However, current treatments are not able to reverse existing damage to heart muscle. Treatment with progenitor cells (i.e., stem cells) offers potential benefits beyond those of standard medical care, including the potential for repair and/or regeneration of damaged myocardium.
Autologous sources for progenitor cells from adult and embryonic donor cells may include skeletal myoblasts, hematopoietic stem cells, & induced pluripotent stem cells all of which are able to differentiate into cardiomyocytes and vascular endothelial cells.
Allogeneic sources for progenitor cells are currently being developed. An example of this is the human mesenchymal stem cell (hMSC) product Prochymal™ which is being developed by Osiris Therapeutics, Inc. for treatment of acute myocardial infarction. Prochymal™ is a highly purified preparation of ex vivo cultured adult hMSC isolated from the bone marrow of healthy young adult donors.
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
Progenitor 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.
See also: Stem Cell Therapy for Peripheral Artery Disease
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ADDITIONAL INFORMATION
Published evidence based studies and support by professional organizations regarding the utilization of progenitor cell therapy for the treatment of damaged myocardium are lacking. Progenitor cell therapy for the treatment of damaged myocardium is a rapidly evolving field, with a number of areas of substantial uncertainty including patient selection, cell type, and procedural details (e.g. timing and mode of delivery).
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (7:2010). Progenitor cell therapy for the treatment of damaged myocardium due to ischemia (2.02.18). Retrieved September 24, 2010 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. (Level 4 Evidence)
Gulati, R., Simari, R. (2007). Cell therapy for acute myocardial infarction. The Medical Clinics of North America, 91 (4), 769-785.
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 regeneration. Regenerative Medicine, 3 (2), 189-198. National Institute of Health. Stem Cell Information. (2006). Mending a broken heart: Stem cells and cardiac repair. Retrieved June 16, 2010 from http://stemcells.nih.gov/info/2006report/2006Chapter6.htm.
Technology Evaluation Center. (2008, September). Autologous progenitor cell therapy for the treatment of ischemic heart disease. (Vol 25, No. 4). Retrieved June 16, 2010 from http://www.bcbs.com/blueresources/tec/vols/23/autologous-progenitor-cell.html. (28 articles and/or guidelines reviewed)
U. S. Food and Drug Administration. (2009, March). Center for Biologics Evaluation and Research. Somatic cell therapy for cardiac disease. Retrieved September 30, 2008 from http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM164345.pdf.
ORIGINAL EFFECTIVE DATE: 4/12/2007
MOST RECENT REVIEW DATE: 2/13/2011
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