Mann I, Tseng C C S, Rodrigo S F, Koudstaal S, van Ramshorst J, Beeres S L, Dibbets-Schneider P, de Geus-Oei L F, Lamb H J, Wolterbeek R, Zwaginga J J, Fibbe W E, Westinga K, Bax J J, Doevendans P A, Schalij M J, Chamuleau S A J, Atsma D E
Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands.
Department of Cardiology, University Medical Center Utrecht, Utrecht, The Netherlands.
Neth Heart J. 2019 Feb;27(2):81-92. doi: 10.1007/s12471-018-1213-2.
It has been suggested that bone marrow cell injection may have beneficial effects in patients with chronic ischaemic heart disease. However, previous trials have led to discrepant results of cell-based therapy in patients with chronic heart failure. The aim of this study was to evaluate the efficacy of intramyocardial injection of mononuclear bone marrow cells in patients with chronic ischaemic heart failure with limited stress-inducible myocardial ischaemia.
This multicentre, randomised, placebo-controlled trial included 39 patients with no-option chronic ischaemic heart failure with a follow-up of 12 months. A total of 19 patients were randomised to autologous intramyocardial bone marrow cell injection (cell group) and 20 patients received a placebo injection (placebo group). The primary endpoint was the group difference in change of left ventricular ejection fraction, as determined by single-photon emission tomography. On follow-up at 3 and 12 months, change of left ventricular ejection fraction in the cell group was comparable with change in the placebo group (P = 0.47 and P = 0.08, respectively). Also secondary endpoints, including left ventricle volumes, myocardial perfusion, functional and clinical parameters did not significantly change in the cell group as compared to placebo. Neither improvement was demonstrated in a subgroup of patients with stress-inducible ischaemia (P = 0.54 at 3‑month and P = 0.15 at 12-month follow-up).
Intramyocardial bone marrow cell injection does not improve cardiac function, nor functional and clinical parameters in patients with severe chronic ischaemic heart failure with limited stress-inducible ischaemia.
NTR2516.
有人提出骨髓细胞注射可能对慢性缺血性心脏病患者有益。然而，先前的试验在慢性心力衰竭患者中得出了基于细胞治疗的不一致结果。本研究的目的是评估在应激诱导心肌缺血有限的慢性缺血性心力衰竭患者中，心肌内注射单核骨髓细胞的疗效。
这项多中心、随机、安慰剂对照试验纳入了39例无可选择的慢性缺血性心力衰竭患者，随访12个月。共有19例患者被随机分配接受自体心肌内骨髓细胞注射（细胞组），20例患者接受安慰剂注射（安慰剂组）。主要终点是通过单光子发射断层扫描测定的左心室射血分数变化的组间差异。在3个月和12个月随访时，细胞组左心室射血分数的变化与安慰剂组相当（分别为P = 0.47和P = 0.08）。与安慰剂相比，包括左心室容积、心肌灌注、功能和临床参数在内的次要终点在细胞组中也没有显著变化。在应激诱导缺血患者亚组中也未显示出改善（3个月时P = 0.54，12个月随访时P = 0.15）。
在应激诱导缺血有限的严重慢性缺血性心力衰竭患者中，心肌内骨髓细胞注射不能改善心脏功能、功能和临床参数。
NTR2516。
