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Effect of Transendocardial Delivery of Autologous Bone Marrow

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Effect of Transendocardial Delivery of Autologous Bone Marrow ORIGINAL CONTRIBUTION ONLINE FIRST Effect of Transendocardial Delivery of Autologous Bone Marrow Mononuclear Cells on Functional Capacity, Left Ventricular Function, and Perfusion in Chronic Heart Failure The FOCUS-CCTRN Trial Emerson C. Perin, MD, PhD, James T. Context Previous studies using autologous bone marrow mononuclear cells (BMCs) in Willerson, MD, Carl J. Pepine, MD, Timothy D. patients with ischemic cardiomyopathy have demonstrated safety and suggested efficacy. Henry, MD, Stephen G. Ellis, MD, David X. M. Objective To determine if administration of BMCs through transendocardial injec- Zhao, MD, Guilherme V. Silva, MD, Dejian Lai, tions improves myocardial perfusion, reduces left ventricular end-systolic volume (LVESV), or enhances maximal oxygen consumption in patients with coronary artery disease or PhD, James D. Thomas, MD, Marvin W. LV dysfunction, and limiting heart failure or angina. Kronenberg, MD, A. Daniel Martin, PhD, PT, Design, Setting, and Patients A phase 2 randomized double-blind, placebo-controlled R. David Anderson, MD, MS, Jay H. Traverse, trial of symptomatic patients (New York Heart Association classification II-III or Canadian MD, Marc S. Penn, MD, PhD, Saif Cardiovascular Society classification II-IV) with a left ventricular ejection fraction of 45% Anwaruddin, MD, Antonis K. Hatzopoulos, or less, a perfusion defect by single-photon emission tomography (SPECT), and coronary artery disease not amenable to revascularization who were receiving maximal medical therapy PhD, Adrian P. Gee, PhD, Doris A. Taylor, at 5 National Heart, Lung, and Blood Institute–sponsored Cardiovascular Cell Therapy Re- PhD, Christopher R. Cogle, MD, Deirdre search Network (CCTRN) sites between April 29, 2009, and April 18, 2011. Smith, RN, Lynette Westbrook, RN, James Intervention Bone marrow aspiration (isolation of BMCs using a standardized au- Chen, RN, Eileen Handberg, PhD, Rachel E. tomated system performed locally) and transendocardial injection of 100 million BMCs or placebo (ratio of 2 for BMC group to 1 for placebo group). Olson, RN, MS, Carrie Geither, RN, Sherry Main Outcome Measures Co-primary end points assessed at 6 months: changes Bowman, RN, Judy Francescon, RN, Sarah in LVESV assessed by echocardiography, maximal oxygen consumption, and revers- Baraniuk, PhD, Linda B. Piller, MD, MPH, ibility on SPECT. Phenotypic and functional analyses of the cell product were per- Lara M. Simpson, PhD, Catalin Loghin, MD, formed by the CCTRN biorepository core laboratory. David Aguilar, MD, Sara Richman, Claudia Results Of 153 patients who provided consent, a total of 92 (82 men; average age: Zierold, PhD, Judy Bettencourt, MPH, Shelly 63 years) were randomized (n=61 in BMC group and n=31 in placebo group). Changes in LVESV index (−0.9 mL/m2 [95% CI, −6.1 to 4.3]; P=.73), maximal oxygen con- L. Sayre, MPH, Rachel W. Vojvodic, MPH, sumption (1.0 [95% CI, −0.42 to 2.34]; P=.17), and reversible defect (−1.2 [95% CI, Sonia I. Skarlatos, PhD, David J. Gordon, MD, −12.50 to 10.12]; P=.84) were not statistically significant. There were no differences PhD, Ray F. Ebert, PhD, Minjung Kwak, PhD, found in any of the secondary outcomes, including percent myocardial defect, total defect size, fixed defect size, regional wall motion, and clinical improvement. Lemuel A. Moye´, MD, PhD, Conclusion Among patients with chronic ischemic heart failure, transendocardial in- Robert D. Simari, MD jection of autologous BMCs compared with placebo did not improve LVESV, maximal for the Cardiovascular Cell Therapy Research oxygen consumption, or reversibility on SPECT. Network (CCTRN) Trial Registration clinicaltrials.gov Identifier: NCT00824005 JAMA. 2012;307(16):1717-1726 ELL THERAPY HAS EMERGED AS Published online March 24, 2012. doi:10.1001/jama.2012.418 www.jama.com an innovative approach for treating patients with ad- Author Affiliations and a list of the CCTRN study group vanced ischemic heart dis- studies have been performed primarily are listed at the end of this article. Cease, including those with refractory an- using autologous stem/progenitor Corresponding Author: Lemuel A. Moye´ , MD, PhD, University of Texas, 1200 Pressler, W-848, Houston, gina and/or heart failure. Early clinical cells.1-13 In patients with ischemic heart TX 77030 ([email protected]). ©2012 American Medical Association. All rights reserved. JAMA, April 25, 2012—Vol 307, No. 16 1717 Downloaded From: http://jama.jamanetwork.com/ by a University of Kansas, Participant User on 05/22/2014 BONE MARROW MONONUCLEAR CELLS FOR CHRONIC HEART FAILURE disease and heart failure, treatment with administration of 100ϫ106 total BMCs formity of cell preparation. Briefly, autologous bone marrow mononuclear improves measures of LV performance approximately 80 to 100 mL of bone mar- cells (BMCs) has demonstrated safety and perfusion at 6 months compared row was aspirated from the iliac crest and has suggested efficacy.10,14-17 with baseline levels. using standard techniques. The aspirate None of the clinical trials per- Briefly, we enrolled patients aged 18 was processed with a closed, automated formed to date, however, have been years or older with clinically stable coro- cell processing system21 (Sepax, Biosafe powered to evaluate specific efficacy nary artery disease, LV ejection frac- SA). Composition of CD34 and CD133 measures. In addition, autologous cell tion (LVEF) of 45% or less, limiting an- cells was determined by flow cytom- therapy trials have usually enrolled gina (Canadian Cardiovascular Society etry. After the cells passed stipulated lot older patients with acute or chronic left [CCS] class II-IV) and/or congestive release criteria, including viability ventricular (LV) dysfunction without heart failure (New York Heart Associa- (Ͼ70%) and sterility, randomization was evaluating the effect of these param- tion [NYHA] class II-III), a perfusion performed by the data coordinating cen- eters or cell function on clinical out- defect by single-photon emission com- ter. Treatment assignment was masked come. These factors are important puted tomography (SPECT), and no re- to all but 1 designated cell processing because ischemic heart failure has the vascularization options while receiv- team member at each center not involved potential to limit the beneficial influ- ing guideline-based medical therapy.20 in patient care. The target dose was ences of cellular effects.6,18 The study was conducted at the 5 100ϫ106 total BMCs. The BMC final The present study was undertaken by CCTRN centers; the organizational product was suspended in normal saline the National Heart, Lung, and Blood In- structure and oversight of the CCTRN containing 5% human serum albumin stitute–sponsored Cardiovascular Cell have been described.20 The protocol was and adjusted to a concentration of Therapy Research Network (CCTRN).19 reviewed and approved by the local in- 100ϫ106 cells in 3 mL distributed into It builds on work from a pilot study in stitutional review boards at each cen- three 1-mL syringes. The placebo group Brazil,10 which in turn led to the first ter. All patients provided written in- received a cell-free suspension in the phase 1 randomized trial of autologous formed consent. same volume. BMC therapy for heart failure in the Randomization was computer- Within 12 hours of aspiration, BMCs United States (FOCUS-HF) approved by generated and used variable block sizes or placebo were delivered in 15 sepa- the US Food and Drug Administra- of 6 or 9, randomly selected and strati- rate injections (0.2 mL each) to LV en- tion.16 These initial studies showed that fied by center. All randomized patients docardial regions identified as viable transendocardial delivery of BMCs was underwent baseline testing, bone mar- (unipolar voltage Ն6.9 mV) by elec- feasible and appeared safe in patients row harvesting, and automated cell pro- tromechanical mapping as described with chronic heart failure due to multi- cessing that was performed locally.20 Pa- elsewhere.20 A 2-dimensional echocar- vessel coronary artery disease.10,16 Al- tients were randomized in a 2:1 ratio to diogram was performed immediately af- though these preliminary studies also receive either BMCs or a placebo (cell- ter the injection procedure and on the evaluated LV function, perfusion, and free) preparation. The cell-containing or next day before hospital discharge. Se- functional capacity, a definitive assess- cell-free preparation was delivered to vi- rial measurements of creatine kinase, ment of efficacy was not possible due to able myocardial regions identified dur- creatine kinase MB, and troponin also the small number of patients. Thus, the ing electromechanical mapping of the LV were obtained. All patients remained in present trial was designed as a larger endocardial surface (NOGA, Biologics the hospital overnight and were then study to investigate the effects of tran- Delivery Systems, Cordis Corpora- discharged with instructions for guide- sendocardial-delivered BMCs in pa- tion). All caregivers and patients were line-recommended therapy. Patients tients with chronic ischemic heart dis- masked to treatment. At 6 months, all were examined for safety and efficacy ease and LV dysfunction with heart baseline testing was repeated in an iden- at 6 months. All events deemed to be failure and/or angina.20 tical fashion. potential major adverse clinical events Baseline assessments have been de- were assessed by 2 independent cardi- METHODS scribed.20 Demographic and clinical ologists not affiliated with any clinical A phase 2 randomized
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