Safety and feasibility of percutaneous retrograde coronary sinus delivery of autologous bone marrow mononuclear cell tra

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Safety and feasibility of percutaneous retrograde coronary sinus delivery of autologous bone marrow mononuclear cell transplantation in patients with chronic refractory angina Jorge Tuma1, Roberto Fernández-Viña2, Antonio Carrasco3, Jorge Castillo3, Carlos Cruz1, Alvaro Carrillo1, Jose Ercilla1, Carlos Yarleque1, Jaime Cunza, Timothy D Henry4 and Amit N Patel5*

Abstract Background: Chronic refractory angina is a challenging clinical problem with limited treatment options. The results of early cardiovascular stem cell trials using ABMMC have been promising but have utilized intracoronary or intramyocardial delivery. The goal of the study was to evaluate the safety and early efficacy of autologous bone marrow derived mononuclear cells (ABMMC) delivered via percutaneous retrograde coronary sinus perfusion (PRCSP) to treat chronic refractory angina (CRA). Methods: From May 2005 to October 2006, 14 patients, age 68 +/- 20 years old, with CRA and ischemic stress-induced myocardial segments assessed by SPECT received a median 8.19*108 ± 4.3*108 mononuclear and 1.65*107 ± 1.42*107 CD34+ cells by PRCSP.. Results: ABMMC delivery was successful in all patients with no arrhythmias, elevated cardiac enzymes or complications related to the delivery. All but one patient improved by at least one Canadian Cardiovascular Society class at 2 year follow-up compared to baseline (p < 0.001). The median baseline area of ischemic myocardium by SPECT of 38.2% was reduced to 26.5% at one year and 23.5% at two years (p = 0.001). The median rest left ventricular ejection fraction by SPECT at baseline was 31.2% and improved to 35.5% at 2 year follow up (p = 0.019). Conclusions: PRCSP should be considered as an alternative method of delivery for cell therapy with the ability to safely deliver large number of cells regardless of coronary anatomy, valvular disease or myocardial dysfunction. The clinical improvement in angina, myocardial perfusion and function in this phase 1 study is encouraging and needs to be confirmed in randomized placebo controlled trials.

Background An increasing number of patients with coronary artery disease remain symptomatic with disabling angina despite the optimal use of antianginal medications and percutaneous or surgical revascularization [1,2]. Therapeutic angiogenesis is an experimental strategy utilizing angiogenic proteins, gene therapy or stem cells for inducing neovascularization of chronically ischemic myocardium [3,4]. Currently, the majority of clinical studies investigating autologous bone marrow mononuclear cells * Correspondence: [email protected] 5 University of Utah, Salt Lake City, UT, USA Full list of author information is available at the end of the article

(ABMMC) transplantation as a treatment for ischemic myocardium have been performed in patients with acute myocardial infarction using intracoronary delivery [5-11]. In contrast, in patients with refractory ischemia only a few trials have been published and all have used intramyocardial delivery [12-16]. Percutaneou