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Lancet:心脏干细胞疗法治疗心肌梗塞临床试验获成效

2011-11-17 我要评论0
Tags: 干细胞  心脏  心肌梗塞  

11月14日,英国医学刊物《柳叶刀》(The Lancet)在线发布的研究报告说,美国研究人员用心脏干细胞疗法治疗心肌梗塞的临床试验获得成效。

美国路易斯维尔大学等机构的研究人员报告说,有16名心肌梗塞患者接受了干细胞疗法。心肌梗塞是指由于心血管功能受损等原因,导致心肌缺血而引起的一系列症状,现在常用心血管搭桥手术来缓解症状,即人工连接一段血管,为缺血的心肌部位供血。本次研究使用的干细胞,来源于搭桥手术中取出的心脏组织。

干细胞是还没有完全发育为成体细胞、拥有生长为特定器官潜力的细胞。研究人员在试管中对获得的干细胞进行了培养,在约4个月后将培养所得的大量干细胞注射回其主人的心脏中,期待它们成长为新的健康心脏组织。

结果显示,这些患者由于心肌受损,左心室在一次心跳中将血液正常压出心室的几率原本已降到30.3%,但在接受干细胞治疗后,这一比例已升至38.5%。

研究人员罗伯托·博利说,这是让人惊喜的结果,如果后续研究能进一步支持这种心脏干细胞疗法的有效性,这可能会成为心血管医疗领域的重大进步。(生物谷Bioon.com)

doi:10.1016/S0140-6736(11)61590-0
Cardiac stem cells in patients with ischaemic cardiomyopathy (SCIPIO): initial results of a randomised phase 1 trial

Prof Roberto Bolli MD a , Atul R Chugh MD a, Domenico D'Amario MD d, John H Loughran MD a, Prof Marcus F Stoddard MD a, Prof Sohail Ikram MD a, Garth M Beache MD c, Stephen G Wagner MD a, Annarosa Leri MD d, Toru Hosoda MD d, Fumihiro Sanada MD d, Julius B Elmore MD a, Polina Goichberg PhD d, Donato Cappetta PhD d, Naresh K Solankhi MD a, Ibrahim Fahsah MD a, D Gregg Rokosh PhD a, Prof Mark S Slaughter MD b, Jan Kajstura PhD d, Prof Piero Anversa MD d.

Background

c-kit-positive, lineage-negative cardiac stem cells (CSCs) improve post-infarction left ventricular (LV) dysfunction when administered to animals. We undertook a phase 1 trial (Stem Cell Infusion in Patients with Ischemic cardiOmyopathy [SCIPIO]) of autologous CSCs for the treatment of heart failure resulting from ischaemic heart disease.

Methods

In stage A of the SCIPIO trial, patients with post-infarction LV dysfunction (ejection fraction [EF] ≤40%) before coronary artery bypass grafting were consecutively enrolled in the treatment and control groups. In stage B, patients were randomly assigned to the treatment or control group in a 2:3 ratio by use of a computer-generated block randomisation scheme. 1 million autologous CSCs were administered by intracoronary infusion at a mean of 113 days (SE 4) after surgery; controls were not given any treatment. Although the study was open label, the echocardiographic analyses were masked to group assignment. The primary endpoint was short-term safety of CSCs and the secondary endpoint was efficacy. A per-protocol analysis was used. This study is registered with ClinicalTrials.gov, number NCT00474461.

Findings

This study is still in progress. 16 patients were assigned to the treatment group and seven to the control group; no CSC-related adverse effects were reported. In 14 CSC-treated patients who were analysed, LVEF increased from 30·3% (SE 1·9) before CSC infusion to 38·5% (2·8) at 4 months after infusion (p=0·001). By contrast, in seven control patients, during the corresponding time interval, LVEF did not change (30·1% [2·4] at 4 months after CABG vs 30·2% [2·5] at 8 months after CABG). Importantly, the salubrious effects of CSCs were even more pronounced at 1 year in eight patients (eg, LVEF increased by 12·3 ejection fraction units [2·1] vs baseline, p=0·0007). In the seven treated patients in whom cardiac MRI could be done, infarct size decreased from 32·6 g (6·3) by 7·8 g (1·7; 24%) at 4 months (p=0·004) and 9·8 g (3·5; 30%) at 1 year (p=0·04).

Interpretation

These initial results in patients are very encouraging. They suggest that intracoronary infusion of autologous CSCs is effective in improving LV systolic function and reducing infarct size in patients with heart failure after myocardial infarction, and warrant further, larger, phase 2 studies.



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