11月14日,，英國(guó)醫(yī)學(xué)刊物《柳葉刀》(The Lancet)在線發(fā)布的研究報(bào)告說(shuō),，美國(guó)研究人員用心臟干細(xì)胞療法治療心肌梗塞的臨床試驗(yàn)獲得成效,。
美國(guó)路易斯維爾大學(xué)等機(jī)構(gòu)的研究人員報(bào)告說(shuō),，有16名心肌梗塞患者接受了干細(xì)胞療法。心肌梗塞是指由于心血管功能受損等原因,，導(dǎo)致心肌缺血而引起的一系列癥狀,，現(xiàn)在常用心血管搭橋手術(shù)來(lái)緩解癥狀，即人工連接一段血管,，為缺血的心肌部位供血,。本次研究使用的干細(xì)胞，來(lái)源于搭橋手術(shù)中取出的心臟組織,。
干細(xì)胞是還沒(méi)有完全發(fā)育為成體細(xì)胞,、擁有生長(zhǎng)為特定器官潛力的細(xì)胞。研究人員在試管中對(duì)獲得的干細(xì)胞進(jìn)行了培養(yǎng),，在約4個(gè)月后將培養(yǎng)所得的大量干細(xì)胞注射回其主人的心臟中,，期待它們成長(zhǎng)為新的健康心臟組織。
結(jié)果顯示,，這些患者由于心肌受損,，左心室在一次心跳中將血液正常壓出心室的幾率原本已降到30．3％，但在接受干細(xì)胞治療后,，這一比例已升至38．5％,。
研究人員羅伯托·博利說(shuō)，這是讓人驚喜的結(jié)果,，如果后續(xù)研究能進(jìn)一步支持這種心臟干細(xì)胞療法的有效性,，這可能會(huì)成為心血管醫(yī)療領(lǐng)域的重大進(jìn)步。（生物谷Bioon.com）
doi:10.1016/S0140-6736(11)61590-0
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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.
