BlueCross BlueShield of Tennessee Medical Policy Manual

Progenitor Cell Therapy for the Treatment of Damaged Myocardium Due to Ischemia

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 has 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.

POLICY

IMPORTANT REMINDERS

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

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 Foundation & American Heart Association. (2013). 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction. Retrieved May 10, 2017 from http://circ.ahajournals.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. (5:2018). Progenitor cell therapy for the treatment of damaged myocardium due to ischemia (2.02.18). Retrieved April 23, 2019 from BlueWeb. (30 articles and/or guidelines reviewed)

De Rosa, S., Seeger, F., Honold, J., MD; Fischer-Rasokat, U., Lehmann, R., Fichtlscherer, S., et al. (2013). Procedural safety and predictors of acute outcome of intracoronary administration of progenitor cells in 775 consecutive procedures performed for acute myocardial infarction or chronic heart failure. Circulation: Cardiovascular Interventions, 6 (1), 44-51. (Level 2 evidence)

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)

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:  5/9/2019

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