Effect of intracoronary delivery of autologous bone marrow mononuclear cells 2 to 3 weeks following acute myocardial infarction on left ventricular function: the LateTIME randomized trial.
Effect of intracoronary delivery of autologous bone marrow mononuclear cells 2 to 3 weeks following acute myocardial infarction on left ventricular function: the LateTIME randomized trial.
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DOI：
10.1001/jama.2011.1670
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发表时间：
2011-11-16
影响因子：
120.7
通讯作者：
Simari, Robert D.
中科院分区：
文献类型：
--
作者：
Traverse, Jay H.;Henry, Timothy D.;Ellis, Stephen G.;Pepine, Carl J.;Willerson, James T.;Zhao, David X. M.;Forder, John R.;Byrne, Barry J.;Hatzopoulos, Antonis K.;Penn, Marc S.;Perin, Emerson C.;Baran, Kenneth W.;Chambers, Jeffrey;Lambert, Charles;Raveendran, Ganesh;Simon, Daniel I.;Vaughan, Douglas E.;Simpson, Lara M.;Gee, Adrian P.;Taylor, Doris A.;Cogle, Christopher R.;Thomas, James D.;Silva, Guilherme V.;Jorgenson, Beth C.;Olson, Rachel E.;Bowman, Sherry;Francescon, Judy;Geither, Carrie;Handberg, Eileen;Smith, Deirdre X.;Baraniuk, Sarah;Piller, Linda B.;Loghin, Catalin;Aguilar, David;Richman, Sara;Zierold, Claudia;Bettencourt, Judy;Sayre, Shelly L.;Vojvodic, Rachel W.;Skarlatos, Sonia I.;Gordon, David J.;Ebert, Ray F.;Kwak, Minjung;Moye, Lemuel A.;Simari, Robert D.
临床试验结果表明，如果在心肌梗死(MI)后第一周内给予自体骨髓单个核细胞(BMC)冠状动脉内注射，可能会改善左心室(LV)功能。然而，由于相当数量的患者可能没有早期细胞交付，我们调查了心肌梗死后2-3周自体骨髓细胞交付的疗效。为了确定首次心肌梗死后2-3周冠状动脉内移植自体骨髓细胞是否改善了整体和局部左心功能。LateTIME是一项随机、双盲、安慰剂对照试验，由美国国家心肺血液研究所赞助的心血管细胞治疗研究网络对87名在初次经皮冠状动脉介入治疗成功后出现严重左心功能障碍(≤为45%)的患者进行研究。骨髓抽吸术后12小时内冠状动脉内注入150×106个自体骨髓细胞(总有核细胞)或安慰剂(2：1骨髓基质细胞：安慰剂)。主要终点是心梗和交界区从基线到6个月的整体(LVEF)和局部(室壁运动)左室功能的变化，由核心实验室的心脏MRI测量，与治疗分配无关。次要终点包括左室体积和梗塞面积的变化。在2008年7月至2011年2月期间，87名患者被随机分组：平均年龄为57±11岁，其中83%为男性。在这种环境下采集、加工和冠状动脉内输送骨髓细胞是可行和安全的。与安慰剂组相比，BMC组从基线到6个月的变化包括左心室射血分数(48.7%~49.2%比45.3%~48.8%；差异=−3.0，95%CI−7.0~0.9)、梗死区室壁运动(6.2~6.5vs.4.9~5.9 mm；差异=−0.7，95%CI−2.8~1.3)，交界区室壁运动(16.0~16.6 mm vs 16.1~19.3 mm；差异=−2.6；95%CI−6.0~0.8)无统计学意义。在6个月时，两组患者的左心室体积没有明显变化，而梗塞体积与基线相比减少了相似的量。在经皮冠状动脉介入治疗再灌注后有心肌梗死和左心功能障碍的患者中，冠状动脉内注射自体骨髓细胞与冠状动脉内安慰剂注射相比，术后2-3周的整体或局部功能在6个月时没有改善。
Clinical trial results suggest that intracoronary delivery of autologous bone marrow mononuclear cells (BMCs) may improve left ventricular (LV) function when administered within the first week following myocardial infarction (MI). However, since a substantial number of patients may not present for early cell delivery, we investigated the efficacy of autologous BMC delivery 2–3 weeks post-MI. To determine if intracoronary delivery of autologous BMCs improves global and regional LV function when delivered 2–3 weeks following first MI. LateTIME is a randomized, double-blind, placebo-controlled trial of the National Heart, Lung, and Blood Institute - sponsored Cardiovascular Cell Therapy Research Network (CCTRN) of 87 patients with significant LV dysfunction (LVEF ≤ 45%) following successful primary percutaneous coronary intervention (PCI). Intracoronary infusion of 150 × 106 autologous BMCs (total nucleated cells) or placebo (2:1 BMC:placebo) was performed within 12 hours of bone marrow aspiration after local automated cell processing. The primary endpoints were changes in global (LVEF) and regional (wall motion) LV function in the infarct and border zone from baseline to 6 months as measured by cardiac MRI at a core lab blinded to treatment assignment Secondary endpoints included changes in LV volumes and infarct size. 87 patients were randomized between July 2008 and February 2011: mean age = 57 ± 11 yrs, 83% male. Harvesting, processing, and intracoronary delivery of BMCs in this setting was feasible and safe. The change from baseline to six months in the BMC group, when compared to the placebo group, for LVEF (48.7 to 49.2% vs. 45.3 to 48.8%; Difference = −3.0, 95% CI −7.0 to 0.9), wall motion in the infarct zone (6.2 to 6.5 vs. 4.9 to 5.9 mm; Difference = −0.7, 95% CI −2.8 to 1.3), and wall motion in the border zone (16.0 to 16.6 mm vs. 16.1 to 19.3 mm; Difference = −2.6; 95% CI −6.0 to 0.8) were not statistically significant. There was no significant change in LV volumes and infarct volumes decreased by a similar amount in both groups at 6 months compared to baseline. Among patients with MI and LV dysfunction following reperfusion with PCI, intracoronary infusion of autologous BMCs compared to intracoronary placebo infusion, 2–3 weeks after PCI did not improve global or regional function at 6 months.
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影响因子：
4.8
作者：
Traverse, Jay H.;McKenna, David H.;Harvey, Karen;Jorgenso, Beth C.;Olson, Rachel E.;Bostrom, Nancy;Kadidlo, Diane;Lesser, John R.;Jagadeesan, Vikrant;Garberich, Ross;Henry, Timothy D.
通讯作者：
Henry, Timothy D.
影响因子：
24
作者：
Hare, Joshua M.;Traverse, Jay H.;Henry, Timothy D.;Dib, Nabil;Strumpf, Robert K.;Schulman, Steven P.;Gerstenblith, Gary;DeMaria, Anthony N.;Denktas, Ali E.;Gammon, Roger S.;Hermiller, James B., Jr.;Reisman, Mark A.;Schaer, Gary L.;Sherman, Warren
通讯作者：
Sherman, Warren
影响因子：
37.8
作者：
Shintani, S;Murohara, T;Imaizumi, T
通讯作者：
Imaizumi, T
影响因子：
168.9
作者：
Janssens, S;Dubois, C;Van de Werf, F
通讯作者：
Van de Werf, F
影响因子：
158.5
作者：
Schaechinger, Volker;Erbs, Sandra;Zeiher, Andreas M.
通讯作者：
Zeiher, Andreas M.