Direct intramyocardial transthoracic transplantation of bone marrow mononuclear cells for non-ischemic dilated cardiomyopathy: INTRACELL, a prospective randomized controlled trial Ensaio clínico prospectivo randomizado sobre terapia com células mononucleares da medula óssea para cardiomiopatia di... (original) (raw)
Related papers
Texas Heart Institute journal / from the Texas Heart Institute of St. Luke's Episcopal Hospital, Texas Children's Hospital, 2004
Growing evidence suggests that transplantation of autologous bone-marrow mononuclear cells (ABMMNCs) can improve the perfusion and contractile function of ischemic myocardium. This procedure could potentially benefit transplant candidates awaiting a donor heart. To study the safety and feasibility of ABMMNC injection, we performed a prospective, nonrandomized, open-label study in 5 heart transplant candidates with severe ischemic heart failure. Each patient underwent baseline single-photon emission computed tomography, a ramp treadmill protocol, 2-dimensional echocardiography, 24-hour Holter monitoring, and signal-averaged electrocardiography, which were repeated at 2 and 6 months. Transendocardial delivery of ABMMNCs was done with the aid of electromechanical mapping to identify viable myocardium. Each patient received 15 ABMMNC injections of 0.2 cc each. There were no deaths, significant arrhythmias, or other major complications. The ABMMNC injection reduced the amount of ischemic...
European heart journal, 2015
Pre-clinical and few clinical studies suggest that transplantation of autologous bone marrow mononuclear cells (BMNC) improves heart function in dilated cardiomyopathies. Our objective was to determine if intracoronary injection of autologous BMNC improves the left ventricular ejection fraction (LVEF) of patients with non-ischaemic dilated cardiomyopathy (NIDCM). This study was a multicentre, randomized, double-blind, placebo controlled trial with a follow-up of 12 months. Patients with NIDCM and LVEF <35% were recruited at heart failure ambulatories in specialized hospitals around Brazil. One hundred and sixty subjects were randomized to intracoronary injection of BMNC or placebo (1:1). The primary endpoint was the difference in change of LVEF between BMNC and placebo groups as determined by echocardiography. One hundred and fifteen patients completed the study. Left ventricular ejection fraction decreased from 24.0% (21.6-26.3) to 19.9% (15.4-24.4) in the BMNC group and from 24...
2009
Objective: To determine the feasibility and safety of bone marrow mononuclear cell (BMC) intra-coronary transplantation and 6-months results in patients with STEMI. Material and Method: After successful percutaneous coronary intervention (PCI) in STEMI patients who did not have flow re-established within 12 hours and poor LVEF (less than 50%) by echocardiography were enrolled. Bone marrow aspiration of 100 cc was performed in the morning. After cell processing for 3 hours, the suspension of BMC about 10 cc were infused to infarcted area using standard PCI technique. Balloon occlusion for 3 minutes was performed during cell infusion. Cardiac magnetic resonance imaging was used to determine LVEF, scar volume and LV volume before and 6 months after transplantation.
Journal of Cardiovascular Translational Research, 2009
Intramyocardial transplantation of autologous bone marrow mononuclear cells (BMMC) is believed to be a promising method for the treatment of patients with chronic ischemic heart disease. The aim of this study was to evaluate long-term results of intramyocardial bone marrow cell transplantation in patients with severe ischemic heart failure. One hundred nine patients with chronic myocardial infarction and end-stage chronic heart failure were randomized into two groups: 55 patients received intramyocardial BMMC injection and 54 received optimal medical therapy. The NOGA system (Biosense-Webster) was used to administer 41±16×106 BMMC into the border zone of myocardial infarction. None of the patients developed periprocedural complications following BMMC injections. The injections led to improvement of CCS class (3.1±0.4 to 1.6±0.6 after 6 months and 1.6±0.4 after 12 months; p=0.001) and NYHA functional class (3.3±0.2 to 2.3±0.2 after 6 months and 2.5±0.1 after 12 months; p=0.006). Left ventricular ejection fraction increased significantly in the BMMC group (27.8±3.4% vs 32.3±4.1%; p=0.04) while it tended to decrease in the control group (26.8±3.8% to 25.2± 4.1%; p =0.61). Summed rest score improved in the BMMC group after 12 months (30.2±5.6 to 27.8±5.1; p=0.032). The improvement of stress score was more noticeable (34.5±5.4 to 28.1±5.2; p=0.016). Neither stress nor rest score changed in patients numbers on medical therapy. In BMMC group 6 (10.9%) patients died at 12-month follow-up compared with 21 (38.9%) in control group (log-rank test, p=0.0007). Intramyocardial bone marrow cell transplantation to patients with ischemic heart failure is safe and improved survival, clinical symptoms, and has beneficial effect on LV function
Critical Care, 2003
Introduction Cardiac surgery with cardiopulmonary bypass (CPB) is a recognized trigger of systemic inflammatory response, usually related to postoperative acute lung injury (ALI). As an attempt to dampen inflammatory response, steroids have been perioperatively administered to patients. Macrophage migration inhibitory factor (MIF), a regulator of the endotoxin receptor, is implicated in the pathogenesis of ALI. We have previously detected peak circulating levels of MIF, 6 hours post CPB. Experimental data have shown that steroids may induce MIF secretion by mononuclear cells. This study aims to correlate levels of MIF assayed 6 hours post CPB to the intensity of postoperative pulmonary dysfunction, analysing the impact of perioperative steroid administration.
The Journal of Heart and Lung Transplantation, 2014
BACKGROUND: Bone marrow mononuclear cell (BMMC) transplantation for heart failure has shown inconsistent therapeutic efficacy. METHODS: We enrolled 104 ischemic heart failure patients scheduled for coronary artery bypass surgery (CABG). After 4-to 12-week pharmacotherapy optimization, 39 patients with left ventricular ejection fraction (LVEF) of r45% received injections of BMMC or vehicle intra-operatively into the myocardial infarction border area in a randomized, double-blind manner. RESULTS: The median number of cells injected was 8.4 Â 10 8 (interquartile range [IQR]: 5.2 Â 10 8 to 13.5 Â 10 8 ). We measured LV function and myocardial scar size by magnetic resonance imaging (MRI), and viability by positron emission tomography (PET) and single-photon emission computed tomography (SPECT), pre-operatively and after 1-year follow-up. LVEF, the pre-defined primary end-point measure, improved by a median of 5.6% in the control group (IQR 0.2 to 10.1) and by 4.8% in the BMMC group (IQR À0.5 to 8.2) (p ¼ 0.59). Wall thickening in injected segments rose by a median of 4.5% among controls (IQR À18.1 to 23.9) and by 5.5% in the BMMC group (IQR À6.6 to 26.5) (p ¼ 0.68). Changes in viability by PET and SPECT did not differ between groups. Myocardial scar size by MRI in injected segments rose by a median of 5.1% among controls (IQR À3.3 to 10.8), but fell by 13.1% in the BMMC group (IQR À21.4 to À6.5) (p ¼ 0.0002). CONCLUSIONS: BMMC therapy combined with CABG failed to improve LV systolic function, or viability, despite reducing myocardial scar size.