DESCRIPTION
Progenitor cell therapy describes the use of multipotent cells of various cell lineages (autologous or allogeneic) for tissue repair and/or regeneration. Progenitor cell therapy is being investigated for the treatment of damaged myocardium resulting from acute or chronic ischemia and for refractory angina. The mechanism of benefit after treatment with progenitor cells is not entirely understood. Differentiation of progenitor cells into mature myocytes and engraftment of progenitor cells into areas of the damaged myocardium have been suggested in animal studies using tagged progenitor cells; however, there is controversy concerning whether injected progenitor cells engraft and differentiate into mature myocytes in humans to the degree that might result in clinical benefit. Some examples of progenitor cell therapy include: MyoCell® (U.S. Stem Cell, formerly Bioheart), Ixmyelocel-T (Vericel, formerly Aastrom Biosciences), MultiStem® (Athersys), and CardiAMP™ (BioCardia).
POLICY
Progenitor cell therapy for the treatment of damaged myocardium, including, but not limited to the use of 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.
IMPORTANT REMINDERS
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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 an 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
Afzal, M.R., Samanta, A., Shah, Z, Jeevanantham, V., Abdel-Latif, A., Zuba-Surma, E.K., et al. (2015). Adult bone marrow cell therapy for ischemic heart disease: evidence and insights from randomized controlled trials. Circulation Research, 117 (6), 558-575. Abstract retrieved July 30, 2015 from PubMed database.
American College of Cardiology & American Heart Association. (2014). 2014 AHA/ACC guideline for the management of patients with non-st-elevation acute coronary syndromes. Retrieved December 21, 2021 from https://professional.heart.org/.
American College of Cardiology Foundation & American Heart Association. (2013). 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction. Retrieved May 10, 2017 from https://professional.heart.org/.
Bartunek, J., Terzic, A., Davison, B.A., Flippatos, G.S., Radovanovic, S., Beleslin, B., et al. (2017). Cardiopoietic cell therapy for advanced ischaemic heart failure: results at 39 weeks of the prospective, randomized, double-blind, sham-controlled CHART-1 clinical trial. European Heart Journal, 38 (9), 648-660. (Level 1 evidence)
BlueCross BlueShield Association. Evidence Positioning System. (6:2023). Progenitor cell therapy for the treatment of damaged myocardium due to ischemia (2.02.18). Retrieved March 20, 2024 from www.bcbsaoca.com/eps/. (33 articles and/or guidelines reviewed).
Gyöngyösi, M., Wojakowski, W., Lemarchand, P., Lunde, K., Tendera, M., Bartunek, J. (2015). Meta-analysis of cell-based cardiac studies (ACCRUE) in patients with acute myocardial infarction based on individual patient data. Circulation Research, 116 (8), 1346-1360. (Level 1 evidence)
Lalu, M.M., Mazzarello, S., Zlepnig, J., Dong, Y., Montroy, J., McIntyre, L., et al. (2018). Safety and efficacy of adult stem cell therapy for acute myocardial infarction and ischemic heart failure (SafeCell Heart): A systematic review and meta-analysis. Stem Cells Translational Medicine, 7 (12), 857–866. (Level 2 evidence)
Xiao, C., Zhou, S., Liu, Y., & Hu, H. (2014). Efficacy and safety of bone marrow cell transplantation for chronic ischemic heart disease: a meta-analysis. Medical Science Monitor, 20, 1768-1777. (Level 1 evidence)
Xu, R., Ding, S., Zhao, Y., Pu, J., & He, B. (2014). Autologous transplantation of bone marrow/blood-derived cells for chronic ischemic heart disease: a systematic review and meta-analysis. Canadian Journal of Cardiology, 30 (11), 1370-1377. Abstract retrieved May 9, 2017 from PubMed database.
Zhu, K., Li, J., Wang, Y., Luo, J., Guo, C., et al. (2015). Intramyocardial autologous bone marrow-derived stem cells injection for ischemic heart disease ineligible for revascularization: a systematic review and meta-analysis. Archives of Medical Research, 46 (4), 286-295. Abstract retrieved July 30, 2015 from PubMed database.
ORIGINAL EFFECTIVE DATE: 4/12/2007
MOST RECENT REVIEW DATE: 4/11/2024
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