REVIEW Periprocedural adverse events in cell therapy trials in myocardial infarction and cardiomyopathy: a systematic review Paulino A. Alvarez • Ernst R. Schwarz • Rajesh Ramineni • Phil Myatt • Clay Barbin • Carlos Boissonnet • Anita Phan • Aldo Maggioni • Alejandro Barbagelata Received: 4 April 2012 / Accepted: 11 September 2012 / Published online: 28 September 2012 Ó Springer-Verlag 2012 Abstract Background Cell therapy (CTh) is a promising novel therapy for myocardial infarction (MI) and ischemic car- diomyopathy (iCMP). Recognizing adverse events (AE) is important for safety evaluation, harm prevention and may aid in the design of future trials. Objective To define the prevalence of periprocedural AE in CTh trials in MI and iCMP. Methods A literature search was conducted using the MEDLINE database from January 1990 to October 2010. Controlled clinical trials that compared CTh with standard treatment in the setting of MI and/or iCMP were selected. AE related to CTh were analyzed. Results A total of 2,472 patients from 35 trials were included. There were 26 trials including 1,796 patients that used CTh in MI and 9 trials including 676 patients that used CTh in iCMP. Periprocedural arrhythmia monitoring protocols were heterogeneous and follow-up was short in most of the trials. In MI trials, the incidence of peripro- cedural adverse events (AE) related to intracoronary cell transplantation was 7.5 % (95 % CI 6.04–8.96 %). AE related to granulocyte colony-stimulating factor (GCS-F) used for cell mobilization for peripheral apheresis was 16 % (95 % CI 9.44–22.56 %). During intracoronary transplantation in iCMP, the incidence of periprocedural AE incidence was 2.6 % (95 % CI 0.53–4.67 %). There were no AE reported during transepicardial transplantation and AE were rare during transendocardial transplantation. Conclusions The majority of periprocedural AE in CTh trials in MI occurred during intracoronary transplantation and GCS-F administration. In iCMP, periprocedural AE were uncommon. Avoiding intracoronary route for CTh implantation may decrease the burden of periprocedural AE. Standardization of AE definition in CTh trials is needed. Keywords Myocardial infarction Á Cell therapy Á Adverse events Á Cardiomyopathy Introduction Despite advances in medical, surgical, endovascular and mechanical therapies, myocardial infarction (MI) and heart failure (HF) play a major role in morbidity and mortality, with an estimated 5-year survival of approxi- mately 50 % [1–4]. In this context, cell therapy (CTh) appears to be a promising therapeutic intervention mainly by stimulating endogenous cardiomyocyte progenitors [5]. Published meta-analyses [6–8] show a positive effect in left ventricular ejection fraction. However, prevailing P. A. Alvarez Hospital de Clı ´nicas Jose ´ de San Martin, Universidad de Buenos Aires, Buenos Aires, Argentina E. R. Schwarz Á A. Phan Cedars Sinai Heart Institute, Los Angeles, CA, USA R. Ramineni Á P. Myatt Á C. Barbin Á A. Barbagelata University of Texas Medical Branch, Galveston, USA C. Boissonnet Centro de Educacio ´n Me ´dica e Investigaciones Clı ´nicas, Buenos Aires, Argentina A. Maggioni ANMCO Research Centre, Florence, Italy A. Barbagelata (&) 301 University Blv, 5,106 JSA, Galveston, TX 77555-0553, USA e-mail: nabarbag@utmb.edu 123 Clin Res Cardiol (2013) 102:1–10 DOI 10.1007/s00392-012-0508-3