[心脏病学中细胞治疗的当前观点：正在进行的试验概述]

[Current perspectives in cell therapy in cardiology: an overview of ongoing trials].

作者信息

Scacciatella Paolo, Amato Gianluca, Ebrille Elisa, Levis Mario, Frisenda Valeria, Pompilio Giulio, Marra Sebastiano

机构信息

Struttura Complessa a Direzione Ospedaliera Cardiologia 2, Azienda Ospedaliera Universitaria San Giovanni Battista-Molinette, Torino.

出版信息

G Ital Cardiol (Rome). 2010 Oct;11(10):769-74.

PMID:21246779

Abstract

BACKGROUND

Cardiac cell therapy is still restricted to experimental studies and clinical trials. This investigation is an analytic overview of worldwide ongoing trials and is aimed to show useful findings for planning new clinical trials.

METHODS

Based on the online searching engine of the National Library of Medicine database for clinical trials (www.clinicaltrials.gov), all the ongoing studies registered were analyzed and classified.

RESULTS

On May 30, 2009, 95 studies were registered worldwide: 40 of these were conducted in Europe and 4 in Italy. Phase 1, 2, 3 and 4 studies were 28%, 57%, 14% and 1%, respectively; observational and randomized studies were 22% and 78%, respectively. The clinical setting of enrolled patients was acute coronary syndrome in 43 studies (46%), heart failure in 29 studies (30%), chronic heart disease in 23 studies (24%). The treatment strategies investigated are cytokine-induced cell mobilization in 8% and cell implantation in 92%. The cell types used for direct implantation are mononuclear cells in 81%, endothelial precursor cells CD34+ in 11%, endothelial precursor cells CD133+ in 5%, myoblasts in 2% and adipoblasts in 1% of cases. CONCLUSIONS; The present snapshot of worldwide ongoing clinical trials provides useful information for planning an experimental clinical program on cardiac cell therapy.

摘要

背景

心脏细胞治疗仍局限于实验研究和临床试验。本调查是对全球正在进行的试验的分析综述，旨在为规划新的临床试验提供有用的发现。

方法

基于美国国立医学图书馆临床试验数据库的在线搜索引擎（www.clinicaltrials.gov），对所有注册的正在进行的研究进行分析和分类。

结果

2009年5月30日，全球共注册了95项研究：其中40项在欧洲进行，4项在意大利进行。1期、2期、3期和4期研究分别占28%、57%、14%和1%；观察性研究和随机研究分别占22%和78%。纳入患者的临床情况为急性冠状动脉综合征的有43项研究（46%），心力衰竭的有29项研究（30%），慢性心脏病的有23项研究（24%）。所研究的治疗策略中，细胞因子诱导的细胞动员占8%，细胞植入占92%。直接植入所用的细胞类型中，单核细胞占81%，CD34+内皮祖细胞占11%，CD133+内皮祖细胞占5%，成肌细胞占2%，脂肪母细胞占1%。结论：目前全球正在进行的临床试验概况为规划心脏细胞治疗的实验性临床方案提供了有用信息。