A critical analysis of clinical outcomes reported in stem cell trials for acute myocardial infarction: some thoughts for design of future trials.
A critical analysis of clinical outcomes reported in stem cell trials for acute myocardial infarction: some thoughts for design of future trials.
复制标题
DOI：
10.1007/s11883-013-0341-9
复制
发表时间：
2013-08
影响因子：
5.8
通讯作者：
Cardiovascular Cell Therapy Research Network (CCTRN)
中科院分区：
文献类型：
--
作者：
Szady AD;Pepine CJ;Sharma SV;Cogle CR;Perin EC;Ellis SG;Moyé LA;Cardiovascular Cell Therapy Research Network (CCTRN)
心肌梗死（MI）干细胞治疗的目的是改善临床结局，临床结局的详细信息对于III期试验的适当规划至关重要。我们研究了在急性心肌梗死患者中使用自体骨髓源性干细胞（BMC）的选定II期试验的数据。我们提取了可用的定义和结局数据，并生成了事件的标准化估计值，以进行汇总比较。评价了9项试验（1040例患者）6个月至5年的结果。不良结局差异很大，这些结局的定义普遍缺乏细节。在所有患者中，仅16例（1.5%）发生心力衰竭相关住院，仅43例（4.1%）死亡。缺血相关结局的数量超过心力衰竭结局的10倍。需要制定统一的标准，以更好地定义感兴趣的临床结果。此外，从心力衰竭到缺血相关结果的重新关注似乎是适当的。
The purpose of stem cell therapy for myocardial infarction (MI) is to improve clinical outcomes, and detailed information on clinical outcomes is critical to appropriate planning of phase III trials. We examined data from select phase II trials using autologous bone marrow-derived stem cells (BMCs) in patients with acute MI. We extracted available definitions and outcome data, and generated standardized estimates of events to permit summary comparisons. Nine trials (1040 patients) with results for 6 months to 5 years were evaluated. Adverse outcomes varied widely, and there was a general lack of details in the definitions of these outcomes. Heart failure related hospitalizations occurred in only 16 (1.5%) and death in only 43 (4.1%) of all patients. Ischemia-related outcomes outnumbered heart failure outcomes more than 10-fold. Uniform criteria need to be developed to better define clinical outcomes of interest. Furthermore, a refocus from heart failure to ischemia-related outcomes seems appropriate.
登录
查看更多内容
影响因子：
39.3
作者：
Huikuri, Heikki V.;Kervinen, Kari;Makikallio, Timo H.
通讯作者：
Makikallio, Timo H.
影响因子：
24
作者：
Yousef, Muhammad;Schannwell, Christiana Mira;Strauer, Bodo Eckehard
通讯作者：
Strauer, Bodo Eckehard
影响因子：
158.5
作者：
Schaechinger, Volker;Erbs, Sandra;Zeiher, Andreas M.
通讯作者：
Zeiher, Andreas M.
影响因子：
4.8
作者：
Dill, Thorsten;Schaechinger, Volker;Hamm, Christian
通讯作者：
Hamm, Christian
影响因子：
120.7
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.
通讯作者：
Simari, Robert D.